CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 512 enrolled
Drug / intervention
Tislelizumab +3 moredrug
Likely dose
Tislelizumab 200 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/NCT03430843
NCT03430843Phase 3Completed

A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

BeiGene·interventional·Posted Feb 13, 2018·Updated Oct 26, 2024

In Brief

A Phase 3 clinical trial evaluating Tislelizumab, Paclitaxel, and 2 other interventions for Esophageal Squamous Cell Carcinoma (ESCC). Completed, enrolled 512 participants across 104 sites in 11 countries.

Detailed Summary

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, China, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 13, 2018
Enrollment StartJan 26, 2018
Primary CompletionDec 1, 2020
Study CompletionDec 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.4 years ago

Interventions

Tislelizumabdrug

200 mg administered intravenously (IV)

Paclitaxeldrug

135-175 mg /m² administered IV , or 80-100 mg/m\^2 administered IV according to local guidelines for standard of care

Docetaxeldrug

75 mg/m\^2 administered IV or 70 mg/m\^2 IV in Japan

Irinotecandrug

125 mg/m\^2 administered IV