Trials / Terminated
TerminatedNCT05009953
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is an open-label, parallel, multicentre, phase II study to evaluate the efficacy and safety of irinotecan liposome injection. Eligible patients will be divided into two cohorts according to the criteria for the corresponding cohort. The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV). The patients in cohort 2 will receive irinotecan liposome injection combined with a PD-1 inhibitor, 5-Fluorouracil and Leucovorin.
Conditions
- Advanced Biliary Tract Cancer
- Intrahepatic Cholangiocarcinoma
- Extrahepatic Cholangiocarcinoma
- Gallbladder Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Irinotecan Liposome Injection | Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL |
| DRUG | SG001 | Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL |
| DRUG | Fluorouracil | 5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle |
| DRUG | Leucovorin | Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2023-01-16
- Completion
- 2023-01-16
- First posted
- 2021-08-18
- Last updated
- 2024-07-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05009953. Inclusion in this directory is not an endorsement.