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NOT YET RECRUITING
NCT07677293
PHASE3

Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver Metastases

Sponsor: Peking University

View on ClinicalTrials.gov

Summary

This study is a randomized, controlled, open-label phase III clinical trial, aims to compare the efficacy and safety of Retlirafusp alfa injection plus CAPOX versus the investigator's choice of anti-PD-1 antibody plus CAPOX as first-line treatment in patients with advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC) with liver metastases

Official title: Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy for Previously Untreated, Advanced Gastric or Gastroesophageal Junction Cancer With Liver Metastases: a Randomized, Controlled, Multicenter Phase III Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

332

Start Date

2026-06-26

Completion Date

2028-12-31

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

DRUG

Retlirafusp alfa Injection

Retlirafusp alfa injection,1800mg, Q3w

DRUG

Capecitabine

Capecitabine, Q3W

DRUG

Oxaliplatin

Oxaliplatin, Q3W

DRUG

Sintilimab or Tislelizumab (based on investigator's choice)

Sintilimab or Tislelizumab, Q3w

DRUG

Capecitabine

Capecitabine, Q3W

DRUG

Oxaliplatin

Oxaliplatin, Q3W