drugset / Trial / NCT03478488
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
Timeline
- Start
- 2018-04-16
- Primary completion
- 2024-09-10
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 2.5 mg/kg | Subcutaneous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |