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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
262
Leucovorin 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
2-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.
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITING6-mon PFSR
The incidence of disease progression within the first 6 months of the patient's treatment
Time frame: up to approximately 3 years
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.
Time frame: up to approximately 3 years
mORR
objective response rate based on mRECIST
Time frame: up to approximately 3 years
ORR
objective response rate based on RECISTv1.1
Time frame: up to approximately 3 years
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.
Time frame: up to approximately 3 years
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.
Time frame: up to approximately 3 years
1y-PFSR
The proportion of patients who did not develop tumor progression from enrollment to 1 year of follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 year
2y-OSR
Proportion of patients surviving from the start of enrollment to the full 2 years of follow-up.
Time frame: 2 year
OS
The time between the start of treatment and the patient's death
Time frame: up to approximately 5 years
TRAE
The classification of adverse events during treatment was based on NCI-CTCAE v5.0 criteria.
Time frame: up to approximately 3 years
conversion rate
rate of unresectable converted into resectable
Time frame: up to approximately 3 years
PFS
The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.
Time frame: up to approximately 3 years
9-mon PFSR
The incidence of disease progression within the first 9 months of the patient's treatment
Time frame: up to approximately 3 years
18-mon OSR
Proportion of patients surviving from the start of enrollment to the full 18 months of follow-up.
Time frame: 2 years