Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC
NCT06648525 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2024-10-18
Summary
This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).
Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
Interventions
- DRUG
-
Adebrelimab
Adebrelimab, IV
- DRUG
-
Irinotecan liposomes
Irinotecan liposomes, IV
- DRUG
-
Lenvatinib, po
- DRUG
-
5-Fluorouracil (5-FU)
5-Fluorouracil (5-FU), IV
- DRUG
-
Calcium Folinate
Calcium folinate, IV
Sponsors & Collaborators
-
Harbin Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-31
- Primary Completion
- 2027-04-30
- Completion
- 2028-04-30
Countries
- China
Study Locations
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