NCT07151209

Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

A Prospective, Multicenter, Open-label Phase II Single-arm Clinical Trial Protocol on the Efficacy and Safety of Lparomlimab and Tuvonralimab in Combination With Lenvatinib and SOX Chemotherapy in Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial

Conditions

• Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab combined with lenvatinib and SOX	Iparomlimab and Tuvonralimab:5 mg/kg Q3W lenvatinib:8 mg/day orally SOX：oxaliplatin (130 mg/m² Q3W intravenous infusion), and S-1 (40 mg/m² BID orally on days 1-14)

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-03
• Last updated: 2025-09-03