The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.
This is a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and HAIC as conversion therapy. Eligible patients will be randomized into camrelizumab + rivoceranib + HAIC group and camrelizumab + rivoceranib group. Patients in camrelizumab + rivoceranib + HAIC group will receive systemic therapy and no more than 6 cycles HAIC procedure. Tumor response assessment using CT and/or MRI will be conducted according to RECIST v1.1. Those who are assessed as CR/PR or SD and considered suitable for curative hepatic resection will receive surgry. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection.The first administration of postoperative camrelizumab + rivoceranib treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative camrelizumab + rivoceranib treatment. Patients in camrelizumab + rivoceranib group will receive the systemic therapy until progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
398
systemic therapy combined with locoregional theraphy as conversion therapy
systemic therapy
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
R0 rate
R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin
Time frame: 24 months
OS
Overall survival (OS) after randomization, defined as the time from randomization to death from any cause
Time frame: 24 months
EFS
Event-free survival (EFS), defined as the time from randomization to progression (RECIST v1.1), recurrence and death from any cause
Time frame: 24 months
ORR
Objective response rate (ORR), defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.
Time frame: 24 months
DCR
Disease Control Rate (DCR), defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: 24 months
pCR rate
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Pathological complete regression (pCR) rate, defined as the proportion of patients with no evidence of vital residual tumor cells on the complete resected specimen. pCR status will be analyzed by local pathologists at each site
Time frame: 24 months
MPR rate
MPR rate, defined as the proportion of patients with evidence of vital residual tumor cells \<50% on the resected specimen. MPR status will be analyzed by local pathologists at each site
Time frame: 24 months
AE
Adverse events are graded according to the NCI-CTCAE (Version 5.0)
Time frame: 24 months