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Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 997

Last updated 2025-02-14

Study results available
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Summary

This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

  • Gastric, or Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Tislelizumab

200 mg intravenously (IV) on Day 1 of each 21-day cycle

DRUG

Placebo

Placebo to match tislelizumab IV on Day 1 of each 21-day cycle

DRUG

Cisplatin

80 mg/m² IV on Day 1 of each 21-day cycle

DRUG

Oxaliplatin

130 mg/m² IV on Day 1 of each 21-day cycle

DRUG

Capecitabine

1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle

DRUG

5-Fluorouracil

800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Jin Wang, MD · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2023-02-28
Completion
2024-08-27
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Italy
  • Japan
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • 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 NCT03777657 on ClinicalTrials.gov