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

NCT03783442 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 649

Last updated 2025-07-29

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Cisplatin

Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan.

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m² administered by intravenous infusion every 3 weeks.

DRUG

Fluorouracil (5-FU)

Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle.

DRUG

Capecitabine

Capecitabine 1000 mg/m² administered orally twice daily on Days 1-14 of each treatment cycle

DRUG

Paclitaxel

Paclitaxel 175 mg/m² administered by intravenous infusion every 3 weeks.

BIOLOGICAL

Tislelizumab

Tislelizumab 200 mg administered by intravenous infusion every 3 weeks.

DRUG

Placebo

Placebo to match tislelizumab administered by intravenous infusion every 3 weeks.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2022-02-28
Completion
2024-08-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT03783442 on ClinicalTrials.gov