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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

ConditionGastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Retlirafusp alfa Injection

    Drug

    Retlirafusp alfa injection,1800mg, Q3w

  • Capecitabine

    Drug

    Capecitabine, Q3W

  • Oxaliplatin

    Drug

    Oxaliplatin, Q3W

  • Sintilimab or Tislelizumab (based on investigator's choice)

    Drug

    Sintilimab or Tislelizumab, Q3w

  • Capecitabine

    Drug

    Capecitabine, Q3W

  • Oxaliplatin

    Drug

    Oxaliplatin, Q3W

Treatment groups

332 Participants
are divided into 2 treatment groups
Group A: Retlirafusp alfa GroupExperimental treatment 3 interventions
Group B: Investigator's choice of anti-PD-1 antibody GroupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1

Time frame
Up to 2 years

Secondary outcomes

1

Overall survival (OS)

Time frame
Up to approximately 5 years
2

Objective response rate (ORR) based on investigator assessment according to RECIST 1.1

Time frame
Up to 2 years
3

Disease control rate (DCR) based on investigator assessment according to RECIST 1.1

Time frame
Up to 2 years
4

Duration of response (DoR) based on investigator assessment according to RECIST 1.1

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: