A Phase 2 interventional study of Adebrelimab in Intrahepatic Cholangiocarcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
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.
913 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Surufatinib: 100 mg orally qd, Adebrelimab: 1200 mg, IV, q3w, HAIC: Irinotecan liposome 30 mg/m2, leucovorin 200 mg/m2, 5-FU 200 mg/m2 bolus followed by continuous infusion of 5-FU 1200 mg/m2 5-FU q3W for 24 h. Dose adjustment was allowed for instilled drugs during treatment, and delayed administration was allowed for up to 8 weeks, calculated from the last administration time, otherwise treatment was terminated. Tumor assessment will be performed by imaging method every 3 cycles (± 7 days) in 21-day cycles until disease progression (RECIST 1.1) or death (during treatment), and tumor treatment and survival status after disease progression will be recorded.
Drug: Adebrelimab
Adebrelimab, Surufatinib and HAIC
Also known as: Surufatinib, HAIC
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
Plan to share: No
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Tianjin Medical University Cancer Institute and Hospital