This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.
Age 18-75, male or female;
The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C.
Child-pugh liver function grading: Grade A or B
Did not received any type of other first-line drugs such as Sorafenib
Have received immunotherapeutic drugs or interferon in the past.
Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy.
Female subjects with pregnancy or on feeding.
Patients with congenital or acquired immune deficiencies.
Parallel
intravenous FOLFOX7 plus Camrelizumab and apatinib
DrugLeucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg，po，qd for every 21 days
HAIC-FOLFOX plus Camrelizumab and apatinib
Drug2-h infusion of oxaliplatin at 85 mg/m2 ,a 2-3-h administration of leucovorin at 200 mg/m2 , Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h. Camrelizumab (200 mg intravenously, commencing in 7 days after the first HAIC cycle and repeated every 21 days) and apatinib (250 mg daily, taken orally, beginning in 7 days after the initial HAIC cycle). Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg，po，qd for every 21 days.
6-mon PFSR
The incidence of disease progression within the first 6 months of the patient's treatment
Hepatic Reserve Function Impairment Rate(ICG-15min)
ICG-R15 is a clinical parameter that assesses the volume of remaining functional hepatocytes, which reflects the functional reserve status of the liver. It is the most commonly used indicator for measuring the severity of liver damage.
mORR
objective response rate based on mRECIST
ORR
objective response rate based on RECISTv1.1
DOR
Proportion of patients who achieved complete response (CR) or partial response (PR) at the end of treatment, based on mRECIST criteria. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase.
DCR
The percentage of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable (SD) cases. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase.
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