Hepatectomy combined with targeted and immunotherapy for CNLC stage IIIb hepatocellular carcinoma: a single-arm clinical trials protocol

Abstract

ABSTRACTIntroductionCurrent clinical guidelines recommend systematic antitumor therapy as the primary treatment option for patients with stage IIIb hepatocellular carcinoma (HCC) based on the China liver cancer staging (CNLC) criteria. Several different targeted therapeutics have been applied in combination with immunotherapeutic regimens to date in patients with advanced HCC. The present study was developed to evaluate the relative safety and efficacy of hepatectomy in combination with targeted apatinib treatment and immunotherapeutic camrelizumab treatment CNLC-IIIb stage HCC patients with the goal of providing evidence regarding the potential value of this therapeutic regimen in individuals diagnosed with advanced HCC.Methods and analysisThis is a single-arm multicenter clinical trial in which patients undergo hepatectomy in combination with targeted treatment (apatinib) and immunotherapy (camrelizumab). Patients will undergo follow-up every 2-3 months following treatment initiation to record any evidence of disease progression and adverse event incidence for a minimum of 24 months following the discontinuation of treatment until reaching study endpoint events or trial termination. The primary endpoint for this study is patient mortality.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Guangxi Medical University Cancer Hospital for Human Study (reference number KS2022[124]). The results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT05062837.Strengths and limitations of this studyThis study will be the first to assess the relative safety and efficacy of hepatectomy combined with targeted and immunotherapeutic treatment in CNLC-IIIb HCC patients.As a multicenter study, the results of this analysis will be representative, generalizable, and reliable.As this study will entail a prolonged follow-up period, it is critical that participants be thoroughly informed prior to enrollment, with individuals exhibiting high compliance being chosen for study inclusion.