This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
326
Oxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.
Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-Free Survival (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
Overall Survival(OS)
The time between the start of treatment and the patient's deathTime.
Time frame: up to approximately 5 years
Objective Response Rate(ORR)
ORR is defined as the proportion of patients who achieve a reduction in tumor size by a predefined amount within the shortest time frame based on REClSTv1.1. ORR is defined as the sum of partial response (PR) and complete response (CR), that is, the proportion of patients who achieve either PR or CR.
Time frame: up to approximately 3 years
During of response(DOR)
how long a disease continues to respond to a treatment after the initial response is achieved, without the disease getting worse again based on RECIST v1.1.
Time frame: up to approximately 3 years
Disease control rate(DCR)
The percentage of patients whose tumors shrink or stabilize for a certain period otime, including complete response (CR), partial response (PR), and stable (SD) cases. Patientswere evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3months during the sequential treatment phase.
Time frame: up to approximately 3 years
Time to progression(TTP)
It is defined as the time from the start of treatment (or randomisation) until the objective documentation of disease progression based on RECIST v1.1.
Time frame: up to approximately 3 years.
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Progression-Free Survival based on mRECIST(mPFS)
The time from the start of treatment to the first progression of the patient's diseaseTime based on mRECIST
Time frame: up to approximately 3 years
Time to progression based on mRECIST(mTTP)
It is defined as the time from the start of treatment (or randomisation) until the objective documentation of disease progression based on mRECIST.
Time frame: up to approximately 3 years.
Disease control rate based on mRECIST(mDCR)
The percentage of patients whose tumors shrink or stabilize for a certain period otime, including complete response (CR), partial response (PR), and stable (SD) cases based on mRECIST. Patientswere evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3months during the sequential treatment phase.Time Frame: up to approximately 3 years
Time frame: up to approximately 3 years
During of response based on mRECIST(mDOR)
how long a disease continues to respond to a treatment after the initial response is achieved, without the disease getting worse again based on mRECIST .
Time frame: up to approximately 3 years
Objective Response Rate based on mREClST(mORR)
ORR is defined as the proportion of patients who achieve a reduction in tumor size by a predefined amount within the shortest time frame based on mREClST. ORR is defined as the sum of partial response (PR) and complete response (CR), that is, the proportion of patients who achieve either PR or CR.
Time frame: up to approximately 3 years
6 months Progression-Free Survival Rate(6-mon-PFSR)
The incidence of disease progression within the first 6 months of the patient's treatment.
Time frame: up to approximately 3 years
12 months Progression-Free Survival Rate(12-mon-PFSR)
The incidence of disease progression within the first 12 months of the patient's treatment.
Time frame: up to approximately 3 years
18 months Progression-Free Survival Rate(18-mon-PFSR)
The incidence of disease progression within the first 18 months of the patient's treatment.
Time frame: up to approximately 3 years.
12 months Overall Survival Rate(12-mon-OSR)
Proportion of patients surviving from the start of enrollment to the full 12 months of follow-up.
Time frame: 2 years
24 months Overall Survival Rate(24-mon-OSR)
Proportion of patients surviving from the start of enrollment to the full 24 months of follow-up.
Time frame: 2 years.
36 months Overall Survival Rate(36-mon-OSR)
Proportion of patients surviving from the start of enrollment to the full 36 months of follow-up.
Time frame: 3 years.
Treatment-related Adverse Event(TRAE)
The classification of adverse events during treatment was based on NCI-CTCAE v5.0 criteria.
Time frame: up to approximately 3 years.
Surgical Conversion Rate
Conversion of initially unresectable patients to resection.
Time frame: up to approximately 3 years.