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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University

About this trial

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

Eligibility criteria

Qualifiers

1. Age ≥ 18 years; 2. Patients with recurrent or previously untreated advanced gastric or gastroesophageal junction cancer with liver metastases, histopathologically confirmed as adenocarcinoma.

Disqualifiers

1. Known gastric cancer of squamous cell carcinoma, undifferentiated carcinoma, or other histological types, or adenocarcinoma mixed with other histological types.

Trial design

Treatments tested in this trial

  • Retlirafusp alfa Injection
  • Capecitabine
  • Oxaliplatin
  • Sintilimab or Tislelizumab (based on investigator's choice)
  • Capecitabine
  • Oxaliplatin

Treatment groups

332 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators