drugset / Trial / NCT06992362

Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach

NCT06992362

Phase 2 Recruiting 30 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if treatment modality including Disitamab Vedotin (RC48), Oxaliplatin,Tegafur,Gimeracil and Oteracil Porassium Capsules (SOX)and Sindillimab works to treat locally advanced hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are: * To evaluate the perioperative efficacy of RC48 combined with sindillizumab and SOX in the treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of RC48 combined with sindillizumab and SOX regimens in perioperative treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach Participants will: * Preoperative treatment with RC48, SOX and sindillizumab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with RC48, Tegafur,Gimeracil and Oteracil Porassium Capsules and sindillizumab for 4 cycles

Timeline

Start
2025-05-20
Primary completion
2026-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2.5 mg/kg Intravenous
Subject Disitamab Vedotin Other / unclassified 200 mg Intravenous
Subject Gimeracil Small molecule Oral
Subject Oteracil Porassium Unknown Oral
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject S-1 Small molecule Oral