Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer (DESTINY-BTC01)

June 11, 2026 updated by: AstraZeneca

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

Study Overview

Status

Recruiting

Conditions

Biliary Tract Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

620

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Australia
- - Chermside, Australia, 4032
    - Recruiting
    - Research Site
  - Clayton, Australia, 3168
    - Recruiting
    - Research Site
  - Concord, Australia, 2139
    - Recruiting
    - Research Site
  - Nedlands, Australia, 6009
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Recruiting
    - Research Site
  - Linz, Austria, 4010
    - Recruiting
    - Research Site
  - Salzburg, Austria, 5020
    - Not yet recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Recruiting
    - Research Site
  - Wiener Neustadt, Austria, 2700
    - Not yet recruiting
    - Research Site
Belgium
- - Anderlecht, Belgium, 1070
    - Recruiting
    - Research Site
  - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Ghent, Belgium, 9000
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
  - Roeselare, Belgium, 8800
    - Recruiting
    - Research Site
Brazil
- - Natal, Brazil, 59012-300
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-000
    - Recruiting
    - Research Site
  - Santa Maria, Brazil, 97015-450
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05651-901
    - Recruiting
    - Research Site
  - Vitória, Brazil, 29043-272
    - Recruiting
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Recruiting
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Recruiting
    - Research Site
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - Recruiting
    - Research Site
China
- - Beijing, China, 100020
    - Recruiting
    - Research Site
  - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China
    - Recruiting
    - Research Site
  - Beijing, China, 100021
    - Withdrawn
    - Research Site
  - Bengbu, China, 233004
    - Recruiting
    - Research Site
  - Changchun, China, 130021
    - Recruiting
    - Research Site
  - Changde, China, 415000
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Changsha, China, 410005
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chengdu, China, 610078
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Withdrawn
    - Research Site
  - Fuzhou, China, 350007
    - Recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Recruiting
    - Research Site
  - Guiyang, China, 550044
    - Recruiting
    - Research Site
  - Hangzhou, China, 310016
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Hefei, China, 230601
    - Recruiting
    - Research Site
  - Hefei, China, 230001
    - Recruiting
    - Research Site
  - Jinan, China, 250117
    - Recruiting
    - Research Site
  - Kunming, China, 650101
    - Recruiting
    - Research Site
  - Linyi, China, 276000
    - Recruiting
    - Research Site
  - Luoyang, China, 471000
    - Recruiting
    - Research Site
  - Nanchang, China, 330029
    - Recruiting
    - Research Site
  - Nanjing, China, 2100008
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Nantong, China, 226001
    - Recruiting
    - Research Site
  - Shanghai, China, 200001
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 201114
    - Recruiting
    - Research Site
  - Shanghai, China, 201107
    - Withdrawn
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shenzhen, China, 518116
    - Not yet recruiting
    - Research Site
  - Tianjin, China, 300060
    - Recruiting
    - Research Site
  - Weifang, China, 261000
    - Recruiting
    - Research Site
  - Wenzhou, China, 325035
    - Recruiting
    - Research Site
  - Wuhan, China, 430079
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450052
    - Recruiting
    - Research Site
Czechia
- - Brno, Czechia, 656 53
    - Recruiting
    - Research Site
  - Brno, Czechia, 625 00
    - Withdrawn
    - Research Site
  - Hradec Králové, Czechia, 500 05
    - Recruiting
    - Research Site
  - Olomouc, Czechia, 77900
    - Recruiting
    - Research Site
  - Prague, Czechia, 15006
    - Recruiting
    - Research Site
  - Prague, Czechia, 100 34
    - Recruiting
    - Research Site
France
- - Brest, France, 29609
    - Recruiting
    - Research Site
  - Clichy, France, 92118
    - Recruiting
    - Research Site
  - Dijon, France, 21079
    - Not yet recruiting
    - Research Site
  - Lille, France, 59037
    - Recruiting
    - Research Site
  - Lyon, France, 69008
    - Recruiting
    - Research Site
  - Lyon, France, 69373
    - Recruiting
    - Research Site
  - Marseille, France, 13008
    - Recruiting
    - Research Site
  - Montpellier, France, 34295
    - Recruiting
    - Research Site
  - Pessac, France, 33604
    - Recruiting
    - Research Site
  - Villejuif, France, 94800
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Recruiting
    - Research Site
  - Cologne, Germany, 50937
    - Recruiting
    - Research Site
  - Dresden, Germany, 01370
    - Recruiting
    - Research Site
  - Frankfurt, Germany, 60488
    - Recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Recruiting
    - Research Site
  - Hamburg, Germany, 22763
    - Recruiting
    - Research Site
  - Leipzig, Germany, 4103
    - Recruiting
    - Research Site
  - Lübeck, Germany, 23538
    - Recruiting
    - Research Site
  - München, Germany, 81377, DE
    - Recruiting
    - Research Site
  - Ulm, Germany, 89081
    - Recruiting
    - Research Site
  - Würzburg, Germany, 97080
    - Recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Research Site
  - Shatin, Hong Kong, 00000
    - Recruiting
    - Research Site
India
- - Dehradun, India, 248016
    - Recruiting
    - Research Site
  - Delhi, India, 110029
    - Recruiting
    - Research Site
  - Delhi, India, 110088
    - Recruiting
    - Research Site
  - Kanpur, India, 208001
    - Recruiting
    - Research Site
  - Kolkata, India, 700094
    - Recruiting
    - Research Site
  - Kolkata, India, 700054
    - Withdrawn
    - Research Site
  - Mumbai, India, 400012
    - Recruiting
    - Research Site
  - Vadodara, India, 391760
    - Recruiting
    - Research Site
  - Varanasi, India, 221005
    - Withdrawn
    - Research Site
Italy
- - Florence, Italy, 50134
    - Recruiting
    - Research Site
  - Milan, Italy, 20132
    - Recruiting
    - Research Site
  - Milan, Italy, 20162
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Naples, Italy, 80128
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Roma, Italy, 00133
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Tricase, Italy, 73039
    - Recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8603
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8677
    - Recruiting
    - Research Site
  - Chiba, Japan, 260-0877
    - Recruiting
    - Research Site
  - Fukuyama-shi, Japan, 721-8511
    - Recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8551
    - Recruiting
    - Research Site
  - Kanazawa, Japan, 920-8641
    - Recruiting
    - Research Site
  - Kashiwa, Japan, 227-8577
    - Recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Recruiting
    - Research Site
  - Kitaadachi-gun, Japan, 362-0806
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kyoto, Japan, 606-8507
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Maebashi, Japan, 371-8511
    - Recruiting
    - Research Site
  - Mitaka-shi, Japan, 181-8611
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Nagoya, Japan, 466-8560
    - Recruiting
    - Research Site
  - Osaka, Japan, 545-8586
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Sakaishi, Japan, 591-8025
    - Recruiting
    - Research Site
  - Sapporo, Japan, 060-8543
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Suita, Japan, 565-0871
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Ube-shi, Japan, 755-8505
    - Recruiting
    - Research Site
  - Wakayama, Japan, 641-8510
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
Malaysia
- - George Town, Malaysia, 10990
    - Recruiting
    - Research Site
  - Johor Bahru, Malaysia, 81100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
Netherlands
- - Rotterdam, Netherlands, 3015 GD
    - Withdrawn
    - Research Site
Philippines
- - Cebu City, Philippines, 6000
    - Not yet recruiting
    - Research Site
  - Makati, Philippines, 1229
    - Not yet recruiting
    - Research Site
  - Pasig, Philippines, 1605
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1112
    - Not yet recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-027
    - Recruiting
    - Research Site
  - Katowice, Poland, 40-514
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-501
    - Recruiting
    - Research Site
  - Lublin, Poland, 20-080
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-034
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 50-556
    - Withdrawn
    - Research Site
Saudi Arabia
- - Dammam, Saudi Arabia, 31444
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11525
    - Not yet recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 12713
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11426
    - Not yet recruiting
    - Research Site
Slovakia
- - Banská Bystrica, Slovakia, 974 01
    - Not yet recruiting
    - Research Site
  - Bratislava, Slovakia, 833 10
    - Recruiting
    - Research Site
  - Košice, Slovakia, 041 91
    - Recruiting
    - Research Site
  - Martin, Slovakia, 036 59
    - Recruiting
    - Research Site
  - Trnava, Slovakia, 917 75
    - Recruiting
    - Research Site
South Korea
- - Busan, South Korea, 48108
    - Recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Research Site
  - Hwasun-gun, South Korea, 58128
    - Recruiting
    - Research Site
  - Seongnam-si, South Korea, 13496
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 05505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 120-752
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Madrid, Spain, 28007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 82445
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 833
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 00807
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 407219
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Muang, Thailand, 50200
    - Recruiting
    - Research Site
  - Mueang, Thailand, 47000
    - Recruiting
    - Research Site
  - Naimuang, Thailand, 30000
    - Recruiting
    - Research Site
  - Ongkharak, Thailand, 26120
    - Recruiting
    - Research Site
  - Si Sa Ket, Thailand, 33000
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Altındağ, Turkey (Türkiye), 06230
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07100
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34218
    - Recruiting
    - Research Site
  - Izmir, Turkey (Türkiye), 35340
    - Recruiting
    - Research Site
  - Mezitli, Turkey (Türkiye), 33200
    - Recruiting
    - Research Site
  - Yakutiye, Turkey (Türkiye), 25040
    - Recruiting
    - Research Site
United Kingdom
- - Birmingham, United Kingdom, B15 2GW
    - Not yet recruiting
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Not yet recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - Research Site
  - Greater London, United Kingdom, SW3 6JJ
    - Recruiting
    - Research Site
  - Leeds, United Kingdom, LS9 7TF
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Research Site
United States
- Arizona
  - Scottsdale, Arizona, United States, 85259
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85719
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85704
    - Withdrawn
    - Research Site
- California
  - Fullerton, California, United States, 92835
    - Recruiting
    - Research Site
  - La Jolla, California, United States, 92093
    - Recruiting
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Suspended
    - Research Site
  - Los Angeles, California, United States, 90089
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90017
    - Recruiting
    - Research Site
  - San Francisco, California, United States, 94143
    - Recruiting
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Not yet recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Not yet recruiting
    - Research Site
- Florida
  - Fort Myers, Florida, United States, 33901
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
  - St. Petersburg, Florida, United States, 33705
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33606
    - Not yet recruiting
    - Research Site
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Recruiting
    - Research Site
- Idaho
  - Coeur d'Alene, Idaho, United States, 83814
    - Withdrawn
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Research Site
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Research Site
- Maryland
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Withdrawn
    - Research Site
  - Worcester, Massachusetts, United States, 01655
    - Withdrawn
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Withdrawn
    - Research Site
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64132
    - Recruiting
    - Research Site
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Withdrawn
    - Research Site
- New York
  - New York, New York, United States, 10032
    - Withdrawn
    - Research Site
  - White Plains, New York, United States, 10601
    - Recruiting
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44111
    - Suspended
    - Research Site
  - Cleveland, Ohio, United States, 44124
    - Suspended
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - Not yet recruiting
    - Research Site
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Withdrawn
    - Research Site
- Texas
  - Austin, Texas, United States, 78705
    - Withdrawn
    - Research Site
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77030
    - Recruiting
    - Research Site
  - Pearland, Texas, United States, 77584
    - Withdrawn
    - Research Site
  - San Antonio, Texas, United States, 78258
    - Withdrawn
    - Research Site
  - San Antonio, Texas, United States, 78217
    - Withdrawn
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Research Site
  - Fairfax, Virginia, United States, 22031
    - Withdrawn
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Withdrawn
    - Research Site
  - Vinh, Vietnam, 460000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.
Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.
Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.
Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)
WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
Adequate organ and bone marrow function within 14 days before randomization.
Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
Minimum life expectancy of 12 weeks.

Key Exclusion Criteria:

Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.
Histologically confirmed ampullary carcinoma.
Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
Medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.
Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening.
Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG.
History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc).
Prior pneumonectomy (complete).
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis/biliary tract infections/biliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.
Active primary immunodeficiency, known uncontrolled active HIV infection or HCV.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).
Any concurrent anticancer treatment without an adequate washout period prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.
History of organ transplants or allogenic stem cell transplant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab deruxtecan Trastuzumab deruxtecan (T-DXd; DS-8201a) arm	Drug: Trastuzumab deruxtecan Experimental therapy by intravenous infusion Other Names: DS-8201a; T-DXd
Experimental: Trastuzumab deruxtecan + rilvegostomig Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm	Drug: Trastuzumab deruxtecan Experimental therapy by intravenous infusion Other Names: DS-8201a; T-DXd Drug: Rilvegostomig Experimental therapy by intravenous infusion
Active Comparator: Standard of Care Gemcitabine and cisplatin in combination with durvalumab arm	Drug: Gemcitabine Standard of care chemotherapy by intravenous infusion Drug: Cisplatin Standard of care chemotherapy by intravenous infusion Drug: Durvalumab Standard of care immunotherapy by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig Time Frame: Until all patients have completed at least 1 full Cycle (each cycle is 21 days)	Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.	Until all patients have completed at least 1 full Cycle (each cycle is 21 days)
Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) population Time Frame: From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)	Overall survival (OS) in FAS (HER2 IHC 3+) population OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS.	From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2024

Primary Completion (Estimated)

June 12, 2028

Study Completion (Estimated)

May 16, 2029

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D781PC00001
2023-508057-19-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
To investigate the immunogenicity of T-DXd and of rilvegostomig Time Frame: From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively	Descriptive summary of presence of ADAs for T-DXd and rilvegostomig in all applicable arms.	From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively
To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population Time Frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)	Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.	From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population Time Frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)	Overall Survival (OS) in FAS (HER2 IHC 3+) population. OS definition as above.	From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population Time Frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)	Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.	From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To further evaluate efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate efficacy of T-DXd monotherapy vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate the efficacy of T-DXd monotherapy vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate efficacy of T-DXd with rilvegostomig vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)	Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR.	From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate efficacy of T-DXd monotherapy vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)	Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR.	From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Overall survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. Time Frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)	Overall survival (OS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS.	From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of PFS in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months)	Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.	From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Duration of response in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months)	Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR.	From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Objective response rate in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To assess the safety and tolerability of T-DXd with rilvegostomig vs Standard of Care Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To assess the safety and tolerability of T-DXd monotherapy vs Standard of Care Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on a summary of symptomatic AEs Time Frame: Until End of Study (estimated up to 50 months)	Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322).	Until End of Study (estimated up to 50 months)
To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs Time Frame: Until End of Study (estimated up to 50 months)	Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322)	Until End of Study (estimated up to 50 months)
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs Time Frame: Until End of Study (estimated up to 50 months)	Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322).	Until End of Study (estimated up to 50 months)
To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs Standard of Care Time Frame: Until End of Study (estimated up to 50 months)	Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. - The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.	Until End of Study (estimated up to 50 months)
To assess time to deterioration in physical functioning in patients treated with T-DXd monotherapy vs Standard of care Time Frame: Until End of Study (estimated up to 50 months)	Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. - The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.	Until End of Study (estimated up to 50 months)
To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy Time Frame: Until End of Study (estimated up to 50 months)	Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. - The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.	Until End of Study (estimated up to 50 months)
To assess the pharmacokinetics of T-DXd, total anti- HER2 antibody, DXd and rilvegostomig in serum Time Frame: From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig	Descriptive analysis of serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in all applicable arms.	From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on overall side-effect bother Time Frame: Until End of Study (estimated up to 50 months)	Patient-reported tolerability will be described using the Overall side-effect bother that will be mesured using PGI-TT	Until End of Study (estimated up to 50 months)
To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on overall side-effect bother Time Frame: Until End of Study (estimated up to 50 months)	Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT	Until End of Study (estimated up to 50 months)
To assess the safety and tolerability of T-DXd with rilvegostomig vs T-DXd monotherapy Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)	Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.	From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To describe patient-reported tolerability of T-DXd with rilvegostmog in comparison to T-DXd monotherapy based on overall side-effect bother Time Frame: Until End of Study (estimated up to 50 months)	Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT.	Until End of Study (estimated up to 50 months)

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer (DESTINY-BTC01)

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Biliary Tract Cancer

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