drugset / Trial / NCT04910386
Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers
Timeline
- Start
- 2027-06-01
- Primary completion
- 2029-06
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |