Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC

• Status: Recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Cisplatin; Paclitaxel

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

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.