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).
This study plans to recruit 68 patients with unresectable ICC who have not received prior systematic treatment. The patients will be randomly divided into two groups. Group A: patients will receive adebrelimab+irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: patients will receive treatment with adebrelimab+irinotecan liposomes+5-fluorouracil+calcium folinate. The combination of irinotecan liposomes+5-fluorouracil+calcium folinate will be used 9 times (Q2W), and adebrelimab ± lenvatinib will be used until disease progression or medication for 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Harbin Medical University
Harbin, Heilongjiang, China
Progression-Free-Survival (PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Time frame: up to 24 months
Objective response rate (ORR)
The proportion of patients with a PR or CR, determined by RECIST v1.1 criteria
Time frame: up to 24 months
Disease control rate (DCR)
The proportion of patients with a PR, CR, or SD
Time frame: up to 24 months
Overall survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Time frame: up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 24 months
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5-Fluorouracil (5-FU), IV
Calcium folinate, IV