drugset / Trial / NCT06772233
A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.
Timeline
- Start
- 2025-07-30
- Primary completion
- 2027-07-30
- Completion
- 2028-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | Regorafenib | Small molecule | 120 mg | Oral |