- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308174
Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer (DEBATE)
Randomized Phase 2 Study of Preoperative Gemcitabine Plus Cisplatin With or Without Durvalumab (MEDI4736) Followed by Postoperative Durvalumab (MEDI4736) in Patients With Localized Biliary Tract Cancer
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Changhoon Yoo, MD, PhD
- Phone Number: +821099006798
- Email: yooc@amc.seoul.kr
Study Locations
-
-
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age > 19 years at time of study entry
- Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma, or gallbladder carcinoma).
- Localized, potentially resectable, non-metastatic disease (determined at the discretion of attending surgeons) based on the results of CT, MRI or PET-CT scans.
- No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy.
- Eastern Cooperative Oncology Group (ECOG performance status of 0 or 1
- Body weight >30kg
- Adequate normal organ and marrow function
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- No other malignant disease apart from non-melanotic skin cancer, carcinoma in situ of the uterine cervix, localized prostate or papillary thyroid cancer, or any other cancer where treated with curative intent > 5 years previously without evidence of relapse
Exclusion Criteria:
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
- Obstruction of gastrointestinal tract
- Active gastrointestinal bleeding
- Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
- Combined hepatocellular carcinoma/cholangiocarcinoma is excluded.
- History of allogenic organ transplantation.
History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Durvalumab + Gem/Cis
<Investigational arm: preoperative phase (up to 4 cycles)> Durvalumab 1,500 mg IV on Day 1, every 3 weeks (preop period) 1,500 mg IV Day 1, every 4 weeks (postop period) Gemcitabine 1,000 mg IV on Day 1 and 8, every 3 weeks Cisplatin 25 mg IV on Day 1 and 8, every 3 weeks <Postoperative therapy for all patients (up to 6 cycles)> Durvalumab 1,500 mg IV Day 1, every 4 weeks (postop period) |
Neoadjuvant Durvalumab + Gemcitabine/Cisplatin
|
Active Comparator: Gem/Cis
<Control arm: preoperative phase (up to 4 cycles)> Gemcitabine 1,000 mg IV on Day 1 and 8, every 3 weeks Cisplatin 25 mg IV on Day 1 and 8, every 3 weeks <Postoperative therapy for all patients (up to 6 cycles)> Durvalumab 1,500 mg IV Day 1, every 4 weeks (postop period) |
Neoadjuvant Gemcitabine/Cisplatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ro resection rate
Time Frame: 4 months
|
Surgical resection without any residual cancer
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 1 year
|
Time between the start of study treatment and any cause of death
|
1 year
|
Event-free survival
Time Frame: 1 year
|
Time between the start of study treatment and disease progression or any cause of death
|
1 year
|
Adverse events
Time Frame: 13 months
|
Number of patients experiencing adverse events graded by National Cancer Institute Common Terminology Criteria version 5
|
13 months
|
Response rate
Time Frame: 4 months
|
Graded by Response Evaluation Criteria in Solid Tumors version 1.1
|
4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Changhoon Yoo, MD, PhD, Asan Medical Center
Publications and helpful links
General Publications
- Kang J, Jeong JH, Hwang HS, Lee SS, Park DH, Oh DW, Song TJ, Kim KH, Hwang S, Hwang DW, Kim SC, Park JH, Hong SM, Kim KP, Ryoo BY, Yoo C. Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response. Cancer Res Treat. 2020 Apr;52(2):594-603. doi: 10.4143/crt.2019.493. Epub 2019 Dec 18.
- Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
- Valle JW, Borbath I, Khan SA, Huguet F, Gruenberger T, Arnold D; ESMO Guidelines Committee. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. doi: 10.1093/annonc/mdw324. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Cholangiocarcinoma
- Biliary Tract Neoplasms
- Gallbladder Neoplasms
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Durvalumab
Other Study ID Numbers
- ESR-18-14059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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