This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma
The combination of anti-angiogenesis and immune checkpoint blockade showed promising outcomes for advanced HCC. Hepatic artery infusion chemotherapy (HAIC) combined with apatinib and camrelizumab could augment treatment efficacy in preliminary study. But HAIC had disadvantages such as technical limitations, expensive cost and poor patient comfort. In the present study, we aimed to investigate the efficacy and safety of Venous Infusion Chemotherapy(VIC) plus camrelizumab and apatinib for CNLC stage Ⅲ HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg,po,qd for every 21 days
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGORR
The Objective Response Rate(ORR) is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1.
Time frame: 1 year
mORR
The mRECIST Objective Response Rate(mORR) is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by mRECIST.
Time frame: 1 year
DOR
The During Of Response(DOR) is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression as assessed by RECIST 1.1 or death (whichever occurs first).
Time frame: 1 year
DCR
The Disease Control Rate(DCR) is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 .
Time frame: 1 year
conversion rate
unresectable converted into resectable
Time frame: 1 year
PFS
The progression-free survival time (PFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 or death, whichever comes earlier.
Time frame: 1 year
OS
Overall survival(OS) is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date.
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Time frame: 1 year
TRAE
Number of participants with treatment-related adverse events as assessed by CTCAE
Time frame: 1 year