Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma
NCT06463548 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-06-18
Summary
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.
Conditions
- Biliary Tract Carcinoma
Interventions
- DRUG
-
irinotecan hydrochloride liposome injection
Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
- DRUG
-
Capecitabine (850 mg/m2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle.
- DRUG
-
Lenvatinib (8 mg) will be administered orally in a 2-week treatment cycle, once a day from day 1 to day 14 of each cycle
Sponsors & Collaborators
-
CSPC Ouyi Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Yunpeng Liu
lead OTHER
Principal Investigators
-
Xiujuan Qu · First Hospital of China Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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