A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

Phase 3 Completed 370 enrolled BeiGene

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC).

Timeline

Start: 2019-06-11
Primary completion: 2025-01-08
Completion: 2025-03-31

Publications

Yu R, Wang W, Li T, Li J, Zhao K, Wang W, Liang L, Wu H, Ai T, Huang W, Li L, Yu W, Wei C, Wang Y, Shen W, Xiao Z. RATIONALE 311: tislelizumab plus concurrent chemoradiotherapy for localized esophageal squamous cell carcinoma. Future Oncol. 2021 Nov;17(31):4081-4089. doi: 10.2217/fon-2021-0632. Epub 2021 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	135 mg/m2	Intravenous

A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

Summary

Timeline

Publications

Drugs

Indications