This study is designed to evaluate the efficacy and safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE as the perioperative adjuvant therapy in surgical resection to hepatocellular carcinoma with high-risk features. (1) Evaluate for some high-risk patients with resectable tumours, whether or not sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE reduces the risk of recurrence and improves the survival of patients. (2) Evaluate the safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE for the neoadjuvant therapy of resectable hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
oxaliplatin 85 mg/m² intra-arterial infusion over 2 hours; leucovorin calcium 200 mg/m² intra-arterial infusion over 2 hours; 5-fluorouracil 400 mg/m² intra-arterial bolus followed by 2400 mg/m² continuous intra-arterial infusion over 46 hours
sintilimab (200 mg intravenous infusion, q3w)
bevacizumab (15 mg/kg intravenous infusion, q3w)
conventional transarterial chemoembolization
2y-RFS
2-year recurrence-free survival rate
Time frame: From date of randomization until date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 2 years
pCR
pathological Complete Response,defined as the absence of residual invasive tumor cells in the primary tumor and regional lymph nodes in the resected specimen after neoadjuvant therapy.
Time frame: Perioperative
MPR
Major Pathological Response,presence of viable tumor cells ≤30% in the primary tumor and lymph nodes after radical resection
Time frame: Perioperative
ORR
Objective Response Rate,the proportion of patients who achieved complete response (CR) or partial response (PR) in tumor shrinkage according to the mRECIST v1.1 criteria and maintained the response for at least 8 weeks
Time frame: Perioperative
R0 resection rate
The proportion of patients who achieved radical R0 resection among those who underwent surgery.
Time frame: Perioperative
EFS
Event-Free Survival, defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, local or distant recurrence, or death from any cause.
Time frame: the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, local or distant recurrence, or death from any cause,assessed up to 2 years
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