drugset / Trial / NCT07677293

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

NCT07677293

Phase 3 Not yet recruiting 332 enrolled Peking University
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2026-06-26
Primary completion
2028-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Retlirafusp alfa Protein / enzyme biologic 1800 mg
Comparator Sintilimab Monoclonal antibody
Comparator Tislelizumab Monoclonal antibody
Comparator Capecitabine Small molecule
Comparator Oxaliplatin Small molecule

Indications