Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC
About the study
This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus P placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- 18 to 75 years on the day of signing the informed consent form
- Histologically confirmed diagnosis of localized ESCC
- Measurable and/or non-measurable disease defined per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Indicators of severe malnutrition
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
- Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
- Active autoimmune diseases or history of autoimmune diseases that may relapse
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Esophageal Squamous Cell Carcinoma (ESCC)
Age (in years)
18 - 75
Phase
Phase 3
Participants needed
370
Est. Completion Date
Dec 30, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT03957590
Study number
BGB-A317-311
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?