Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs. Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma. Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma. Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells. Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R. This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adebrelimab, Surufatinib and HAIC
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Objective Response Rate
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease(PD), using RECIST v1.1
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Disease Control Rate
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease(PD), using RECIST v1.1
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Overall Survival
every two months follow up after EOT observation period at 30 days after the last medication
Time frame: from treatment initiation until death due to any cause, assessed up to 3 year
Progress-Free Survival
every two months follow up after EOT observation period at 30 days after the last medication
Time frame: from treatment initiation until death due to any cause, assessed up to 2 year
Incidence and severity of AE and SAE
Safety
Time frame: from first dose to 30 days post the last dose
Dose suspension rate caused by adverse events
Safety
Time frame: from first dose to 30 days post the last dose
dose termination rate caused by adverse events
Safety
Time frame: from first dose to 30 days post the last dose
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