This is a randomized, double-blinded, controlled, phase II study. The purpose is to evaluate efficacy and safety of the combination therapy of HAIC (Hepatic arterial infusion chemotherapy) with HLX10 (PD-1 antibody) and HLX04 (VEGF antibody) compared with HAIC and placebo in patients with hepatocellular carcinoma with major portal vein tumor thrombosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
For the HAIC procedure, a 5F catheter was introduced using the Seldinger technique through the femoral artery or the radial artery. Then, angiographic surveys of the celiac trunk and superior mesenteric artery were performed. According to tumor size, location, and arterial supply, the catheter or a 2.7F microcatheter was advanced into the hepatic artery at the level of selective segmental, lobar, or whole liver. The catheter or microcatheter was connected to an external infusion pump. The following regimen of modified FOLFOX was administered: oxaliplatin, 85mg/m2 for 2 hours; leucovorin, 400mg/m2; and 5-fluorouracil, 2400mg/m2 for 44-46 hours. After HAIC treatment, the catheter or microcatheter, and the sheath were removed.
PD-1 antibody with proven efficacy in advanced hepatocellular carcinoma
Objective response rate
efficacy
Time frame: The proportion of patients with complete response or partial response, through study completion, an average of 3 years.
Progression free survival
efficacy
Time frame: From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months
Duration of response
efficacy
Time frame: From date of randomization until the date of first documented progression, up to 48 months
Time to response
efficacy
Time frame: From date of randomization until the date of first documented response, up to 48 months
Time to progression
efficacy
Time frame: From date of randomization until the date of first documented progression, up to 48 months
Overall survival
efficacy
Time frame: From date of randomization until death from any cause, up to 48 months
Progression free survival rate at 12-month time point
efficacy
Time frame: From date of randomization until 12-month time point
Overall survival rate at 12-month time point
efficacy
Time frame: From date of randomization until 12-month time point
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Combination of PD-1 antibody and VEGF antibody might promote the efficacy of HAIC in hepatocellular carcinoma with major portal vein thrombosis.
Placebo