drugset / Trial / NCT05009953
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.
Timeline
- Start
- 2021-09-01
- Primary completion
- 2023-01-16
- Completion
- 2023-01-16
Outcome
Outcome not reported
Stopped (Business): “Internal strategy change. Not related to safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enlonstobart | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Irinotecan | Small molecule | 43 mg | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |