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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2026-06-30

No results posted yet for this study

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

Conditions

  • Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

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

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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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 NCT07677293 on ClinicalTrials.gov