drugset / Trial / NCT05350943
HAIC Combined With Toripalimab and Donafenib for Advanced BTC
NaSingle-groupOpen-labelTreatment
Summary
This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.
Timeline
- Start
- 2022-03-01
- Primary completion
- 2022-11
- Completion
- 2023-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donafenib | Small molecule | 0.2 mg | Oral |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |