NCT06227325

Disitamab Vedotin Combined With Sintilimab and XELOX Perioperative Treatment for Resectable Gastric Caner With HER2 Overexpression

Prospective, Single Center, Phase II Study of Disitamab Vedotin（RC48) Combined With Sintilimab Plus XELOX for Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of RC48 combined withSintilimab and chemotherapy in perioperative therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	RC48 combined with Sintilimab and XELOX	RC48: 2.5 mg/kg, iv, d1, repeat every 2 weeks; Sintilimab: 200mg, iv, d1, repeat every 3 weeks; XELOX: Oxaliplatin 130mg/m2, iv, d1；Capecitabine1000 mg po, bid, d1-14, repeat every 3 weeks

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-01-26
• Last updated: 2024-01-26

Locations

1 site across 1 country: China