Research Article: Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol
Abstract:
Introduction Current clinical guidelines recommend systematic antitumour therapy as the primary treatment option for patients with stage IIIb hepatocellular carcinoma (HCC) based on the China liver cancer (CNLC) staging 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 of HCC 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 analysis This is a multicentre phase II trial with single-arm 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 dissemination This study protocol was approved by the Ethics Committee of the Guangxi Medical University Cancer Hospital (KS2022[124]). The results of this study will be submitted for publication in a peer-reviewed journal. Trial registration number NCT05062837 .
Introduction:
Hepatocellular carcinoma (HCC) is the seventh most common form of cancer and causes roughly 830?000 deaths annually. 1 As early-stage HCC generally fails to exhibit any specific symptoms, patients are primarily diagnosed with this disease when it is already in a more advanced stage in China. 2 Between 2003 and 2013, our group identified 6241 patients with HCC in the Guangxi Medical University Cancer Hospital, with 54% of these patients exhibiting disease consistent with stage C Barcelona Clinic Liver Cancer (BCLC)…
Read more