The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.
Our previous study showed that hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib was more effective and safe than sorafenib for hepatocellular carcinoma with portal vein tumor thrombus. Programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus toripalimab with HAIC plus sorafenib. Thus, the investigators carried out this prospective, randomized, non-comparative study to find out it.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
240mg intravenously every 3 weeks
400mg bid po
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression free survival rate at 6 months
Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause
Time frame: 6 months
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Time frame: 6 months
Progression free survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
Time frame: 6 months
Objective response rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Time frame: 6 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Time frame: 6 months
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atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on