Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE).
HuaXi hospital
Chengdu, Sichuan, China
RECRUITINGOverall survival
Time from randomization to death (any cause).
Time frame: 3-year
Adverse events
The occurrence of any hematological or non-hematological toxicity event (≥ class Ⅲ), including but not limited to impaired liver function, impaired hematological system, hypertension, diarrhea, proteinuria, hand-foot syndrome, etc. Severity of adverse events will be graded according to CTCAE v5.0.
Time frame: 2 years
Objective response rate
The percentage of patients achieving complete response and partial response among all patients. Response to treatment will be evaluated according to mRECIST.
Time frame: 2 years
Disease control rate
The percentage of patients with complete response, partial response and stable disease among all patients.
Time frame: 2 years
Event-free survival
Time from randomization to disease progression, local recurrence, distant metastasis, or death, whichever occurs first, assessed by mRECIST
Time frame: 2 years
Overall survival at 2 years
The time from start of treatment until death from any cause or the end of the study (the last enrolled patient should be followed for at least 2 years
Time frame: 2 years
Conversional resection rate
conversional resection patients/enrolled patients
Time frame: 2 years
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