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A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2024-10-26

Study results available
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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.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Tislelizumab

200 mg administered intravenously (IV)

DRUG

Paclitaxel

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

DRUG

Docetaxel

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

DRUG

Irinotecan

125 mg/m\^2 administered IV

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-26
Primary Completion
2020-12-01
Completion
2022-12-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • France
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT03430843 on ClinicalTrials.gov