NCT07127822

Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer

A Randomized, Controlled, Non Inferiority Phase II Clinical Study Comparing Iparomlimab and Tuvonralimab With Standard Chemotherapy Combined With PD-1/PD-L1 Monoclonal Antibody as First-line Treatment for MSI-H/dMMR Recurrent/Metastatic Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer

Detailed description

This is a randomized controlled, non-inferiority design phase II study in the first-line treatment of recurrent/metastatic MSI-H gastric cancer, using iparomlimab and tuvonralimab and standard first-line chemotherapy combined with PD-1/PD-L1 antibody in two cohorts, respectively,

Conditions

• Gastric / Gastroesophageal Junction Adenocarcinoma
• MSI-H Cancer

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab	Iparomlimab and tuvonralimab for experimental arm
DRUG	First line chemotherapy plus PD-1/PD-L1 antibody	standard first-line chemotherapy（FOLFOX/XELOX/SOX）combined with PD-1/PD-L1 antibody for control arm

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: China