CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 370 enrolled
Drug / intervention
Tislelizumab +4 moredrug
Likely dose
Paclitaxel 135 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03957590
NCT03957590Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma

BeiGene·interventional·Posted May 21, 2019·Updated Apr 13, 2026

In Brief

A Phase 3 clinical trial evaluating Tislelizumab, Placebo, and 3 other interventions for Esophageal Squamous Cell Carcinoma (ESCC). Completed, enrolled 370 participants across 33 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Squamous Cell Carcinoma (ESCC)
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 21, 2019
Enrollment StartJun 11, 2019
Primary CompletionJan 8, 2025
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.1 years ago

Interventions

Tislelizumabdrug

Administered intravenously (IV)

Placebodrug

Placebo to match tislelizumab administered intravenously

Paclitaxeldrug

Administered as 135 mg/m² IV injection

Cisplatindrug

Administered as 25 mg/m² IV injection

Radiotherapyradiation

Administered at a total dose of 50.4 Gy in 28 fractions