A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

October 23, 2024 updated by: BeiGene

A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
512

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis Bonheiden
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer hospital
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat Sen University
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat Sen University
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital of Shantou University Medical College
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Xiangyang, Hubei, China, 441021
        • Xiangyang Central Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • The First Peoples Hospital of Changzhou
      • Huaian, Jiangsu, China, 223002
        • Huaian Second Peoples Hospital
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
      • Nantong, Jiangsu, China, 226000
        • Nantong Tumor Hospital Branch South
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Province Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Shaanxi
      • Xian, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Linyi, Shandong, China, 276001
        • Linyi Cancer Hospital
      • Weifang, Shandong, China, 261000
        • Weifang Peoples Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Shanxi Provincial Peoples Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610071
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650100
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital, Zhejiang University School of Medicine
  • France
      • Brest, France, 29200
        • Chru de Brest Hospital Morvan
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Doubs, France, 25030
        • CHU Besançon Hopital Jean Minjoz
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Montpellier, France, 34090
        • Icm Val Daurelle
      • Pessac, France, 33600
        • CHU Bordeaux Hôpital Haut Lévèque
      • Poitiers, France, 86000
        • Chu de Poitiers Site de La Mileterie
      • SaintHerblain, France, 44805
        • Ico Site Rene Gauducheau
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Berlin
      • Leipzig, Germany, 04103
        • Universitares Krebszentrum Leipzig
      • Mainz, Germany, 55131
        • Klinikum Johannes Gutenberg Universitaet Mainz
  • Italy
      • Faenza, Italy, 48018
        • Ospedale Di Faenza
      • Meldola, Italy, 47014
        • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
      • Orbassano, Italy, 10043
        • Azienda Ospedaliero Universitaria San Luigi Gonzaga
      • Pisa, Italy, 56126
        • Aou Pisana, Stabilimento Di Santa Chiara
      • Torino, Italy, 10126
        • Ao Citta Della Salute E Della Scienza Di Torino Presidio O
  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kochi, Japan, 781-8555
        • Kochi Health Sciences Center
      • Kyoto, Japan, 6068507
        • Kyoto University Hospital
    • Akita
      • Akitashi, Akita, Japan, 010-8543
        • Akita University Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyamashi, Ehime, Japan, 791-0280
        • NHO Shikoku Cancer Center
    • Fukuoka
      • Fukuokashi, Fukuoka, Japan, 811-1395
        • Nho Kyushu Cancer Center
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 216-8511
        • St Marianna University School of Medicine Hospital
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Osakashi, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Suitashi, Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Takatsukishi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
    • Saitama
      • Kitaadachigun, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shizuoka
      • Suntogun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tokyo
      • Chuoku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Kotoku, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital Of JFCR
  • Korea, Republic of
    • Gyeonggi-do
      • Seongnamsi, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Incheon Gwang'yeogsi
      • Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Jeollanam-do
      • HwasunGun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Asan Medical Center
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 8036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall dHebron
      • Barcelona, Spain, 08908
        • Institut Catala Doncologia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28050
        • Hospital Universitario Hm Madrid Sanchinarro
      • Madrid, Spain, 28041
        • Hospital Universitario de Octubre
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 736
        • Chi Mei Hospital liouying
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital East Campus
  • United Kingdom
      • Greater Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas Hospital Nhs Foundation Trust
      • London, United Kingdom, W2 1NY
        • St Marys Hospital Imperial College Healthcare Nhs Trust
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Hospital (Mount Vernon Cancer Center)
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Nhs Foundation Royal Marsden Hospital
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
  2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
  3. At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Key Exclusion Criteria:

  1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
  2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
  3. Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
  4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  5. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
  6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
  7. Active brain or leptomeningeal metastasis.
  8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
  9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
  10. Known history of Human Immunodeficiency Virus (HIV)
  11. Has cardiovascular risk factors
  12. Pregnant or breastfeeding woman.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tislelizumab
Tislelizumab on Day 1, given every 21 days
Drug: Tislelizumab
200 mg administered intravenously (IV)
Other Names:
  • BGB-A317
Active Comparator: Investigator chosen chemotherapy (ICC)
Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days
Drug: Irinotecan
125 mg/m^2 administered IV
Drug: Paclitaxel
135-175 mg /m² administered IV , or 80-100 mg/m^2 administered IV according to local guidelines for standard of care
Drug: Docetaxel
75 mg/m^2 administered IV or 70 mg/m^2 IV in Japan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set
Time Frame: Approximately 2 years and 10 months from date of first randomization
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
Approximately 2 years and 10 months from date of first randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in the PDL-1 Positive Analysis Set
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Objective Response Rate (ORR) in the ITT Analysis Set
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Progression-free Survival (PFS) in the ITT Analysis Set
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Duration of Response (DOR) in the ITT Analysis Set
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set
Time Frame: Baseline to Cycle 6 (21 days per cycle)
Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
Time Frame: Baseline to Cycle 6 (21 days per cycle)
Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
Time Frame: Baseline to Cycle 6 (21 days per cycle)
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.
Time Frame: Baseline to Cycle 6 (21 days per cycle)
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set
Time Frame: Baseline to Cycle 6 (21 days per cycle)
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set
Time Frame: Baseline to Cycle 6 (21 days per cycle)
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Baseline to Cycle 6 (21 days per cycle)
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Virginia Paton, Pharm.D., BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-A317-302
  • 2017-003699-30 (EudraCT Number)
  • CTR20171026 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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Conditions

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