Hepatic arterial infusion chemotherapy (HAIC) deliver high concentration of chemotherapeutic agents directly to the liver tumor, was proved to be effective for intrahepatic and perihilar cholangiocarcinoma. Based on the potential synergistic effect of bevacizumab, chemotherapy and PD-1 inhibitor, this phase II clinical study want to test the efficacy and safety using intra-arterial infusion of oxaliplatin, 5-fluorouracil and bevacizumab combined with intravenous infusion of PD-1 inhibitor (Toripalimab) in the treatment of unresectable biliary malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
1. concomitant treatment: A. HAIC: oxaliplatin (40 mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for 22 hours) on days 1-3, and arterial bevacizumab 300mg for 2 hours on d1 before oxaliplatin through a percutaneously implanted port-catheter system. B. Intravenous PD-1 inhibitor (Toripalimab) 240 mg for 30-60 minutes on d1 before the HAIC. The concomitant treatment repeat every three week, up to 6 cycles. 2. Maintenance treatment: Bevacizumab (300mg) + PD-1 inhibitor (Toripalimab 240mg) will be given intravenously, every 3 weeks.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Overall response rate
CR plus PR according to imRECIST
Time frame: From the start of treatment until the end of treatment, up to approximately 3 years
Overall survival
date from the start of treatment until death or lost to follow-up, whichever happen first, assessed at least 6 months
Time frame: From the start of treatment until death or lost to follow-up, up to approximately 3 years
Adverse events
type and incidence of adverse events
Time frame: From the start of treatment until the end of treatment, up to approximately 3 years
Progression-free survival
date from the first treatment to the date of disease progression, lost to follow-up or death, whichever happen first
Time frame: From the start of the treatment until first documented progression or death from any cause, whichever came first, assessed up to approximately 3 yearsse date of disease progression
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