drugset / Trial / NCT06730373
First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
Timeline
- Start
- 2024-10-17
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Disitamab Vedotin | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | S-1 | Small molecule | 40 mg | — |
| Subject | S-1 | Small molecule | 60 mg | — |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | fluorouracil | Small molecule | 800 mg/m2 | — |