drugset / Trial / NCT05394740
Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma.
Timeline
- Start
- 2022-06-06
- Primary completion
- 2024-04-14
- Completion
- 2025-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Regorafenib | Small molecule | 90 mg | Oral |
| Subject | fluorouracil | Small molecule | 1200 mg/m2 | Intravenous |