The study is being conducted to evaluate the efficacy and safety of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib for unresected hepatocellular carcinoma.
A single-arm exploratory clinical study of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib. After screening, subjects who meet the requirements for entry and exclusion signed the informed consent, received carrelizumab combined with apatinib and HAIC for conversion therapy, and After received 2-8 cycles (1 treatment cycle every 21 days) of HAIC combined camrelizumab and apatinib treatment, assess whether the subjects can undergo surgery every 2 cycles during the period: patients who are assessed as being able to undergo radical surgical resection receive elective radical resection surgery, and PD1 antibody should be stopped before surgery For 1 month, TKI drugs will be discontinued for 2-6 weeks; subjects who are assessed as not undergoing radical surgical resection will end this treatment plan. After leaving the group, they can receive any treatment according to the doctor's instructions and continue to follow up until the disease progresses and cannot be tolerated Toxic side effects, withdrawal of informed consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Procedure: 1. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 1st day 30minutes after meals, once a day, for continuous medication. 2. On the 2nd day of treatment, intravenous infusion of Camrelizumab 200mg every 3 weeks. 3. On the 3rd to 4th day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX, oxaliplatin 85 mg/m2 in 0-2 hours, folinic acid 400 mg/m2 in 2-3 hours, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 8 times. The cumulative maximum drug use period is up to 8 cycles. Patient will be administratied radical resection if possible during treatment. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
R0 resection rate
the complete resection rate of all tumor under microscope
Time frame: within 28 working days after operation
Surgical conversion rate
Surgical conversion rate was defined as the proportion of subjects with successful conversion over all subjects who received conversion treatment
Time frame: within 28 working days after operation
MPR
MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
Time frame: within 14 working days after operation
Objective response rate (ORR) by RECIST 1.1 and mRECIST
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 and mRECIST
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 and mRECIST
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) by RECIST 1.1 and mRECIST
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 and mRECIST
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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)
The progression-free survival time (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 and mRECIST
Time frame: From the first documentation of PD to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)
The overall survival time (OS)
OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause.
Time frame: Up to ~4 years
The overall survival rate of 1-year and 2-year(1-year and 2-year OSR)
Up to \~3 years
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)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to ~1 year