drugset / Trial / NCT05218148
SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological remission rate;This prospective phase II clinical trial was designed, using SOX combined with sintilimab and trastuzumab to treat HER2 positive locally advanced gastric or gastroesophageal junction adenocarcinoma patients.
Timeline
- Start
- 2022-04-01
- Primary completion
- 2024-10-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 40 mg | Oral |
| Background | S-1 | Small molecule | 50 mg | Oral |
| Background | S-1 | Small molecule | 60 mg | Oral |