The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab in patients with unresectable hepatocellular carcinoma (HCC).
Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin and raltitrexed was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated HAIC of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
administration of oxaliplatin and raltitrexed via the tumor feeding arteries every 3 weeks.
8 mg once daily (QD) oral dosing.
200mg intravenously every 3 weeks.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Objective response rate (ORR)
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: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The disease control rate (DCR)
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: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
Duration of response (DOR)
DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1
Time frame: From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)
Progression free survival rate at 12 months
The progression free survival time 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
Time frame: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
Overall survival rate at 12 months
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, whichever comes earlier.
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Time frame: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)
The median progression free survival time (mPFS)
The progression free survival time (mPFS) 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
Time frame: From date of first dose of study drug to the date of first documentation of disease progression (up to approximately 3 years)
The median overall survival time (mOS)
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, whichever comes earlier.
Time frame: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Time frame: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)