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

NCT03957590 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-04-13

Study results available
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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).

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Tislelizumab

Administered intravenously (IV)

DRUG

Placebo

Placebo to match tislelizumab administered intravenously

DRUG

Paclitaxel

Administered as 135 mg/m² IV injection

DRUG

Cisplatin

Administered as 25 mg/m² IV injection

RADIATION

Radiotherapy

Administered at a total dose of 50.4 Gy in 28 fractions

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Weihu Wang, MD · Peking University Cancer Hospital & Institute

  • Zefen Xiao, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03957590 on ClinicalTrials.gov