drugset / Trial / NCT07315750
A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
Timeline
- Start
- 2026-01-01
- Primary completion
- 2029-06-30
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Disitamab Vedotin | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |