Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma - a phase II trial protocol

Sep 24, 2026

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Clinical guidelines recommend systematic antitumour therapy as the primary option for patients with stage IIIb hepatocellular carcinoma (HCC) under the China liver cancer (CNLC) staging system. Targeted agents have been combined with immunotherapy for advanced HCC, but comparative safety and efficacy evidence remains limited. This phase II single-arm multicentre protocol evaluates hepatectomy combined with apatinib and camrelizumab, aiming to clarify potential therapeutic value for CNLC-IIIb patients.

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Abstract

Introduction

Strengths and Limitations of This Study

Open access Protocol Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol Jun Tao Huang , Jian-Hong Zhong , Jie Zhang, Wen Feng Gong, Liang Ma, Le Qun Li, Bang-De Xiang To cite: Huang JT, Zhong J-H, Zhang J, et al. Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol. BMJ Open 2023;13:e067730 . doi:10 . 1136/ bmjopen-2022-067730 ► Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ([http://dx.doi.org/10.1136/](http://dx.doi.org/10.1136/)[ ](http://dx.doi.org/10.1136/)[bmjopen-2022-067730](bmjopen-2022-067730)) . Received 24 August 2022 Accepted 24 August 2023 © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Department of Hepatobiliary Surgery, Guangxi Cancer Hospital and Guangxi Medical University Affiliated Cancer Hospital, Nanning, China Correspondence to Dr Jian-Hong Zhong; [zhongjianhong@gxmu.edu](zhongjianhong@gxmu.edu). cn and Professor Bang-De Xiang; [xiangbangde@gxmu.edu.cn](xiangbangde@gxmu.edu.cn) 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 regimensto 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 hepatectomyin 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 peerreviewed 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 STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ This study will be the first to assess the relative safety and efficacy of hepatectomy combined with apatinib and camrelizumab in China liver cancer stage IIIb hepatocellular carcinoma (HCC) patients. ⇒ This multicentre trial will assess a promising combination treatment in patients with advanced HCC with extrahepatic metastases. ⇒ This is a phase II trial with single arm, which is the limitation of the study. consistent with stage C Barcelona Clinic Liver Cancer (BCLC) Staging.2 Similarly, studies conducted in Hong Kong (n=3856) and Italy (n=5183) have, respectively, reported stage CHCC patient proportions of 40% and 45%

FAQs

What treatment regimen does this phase II trial evaluate for CNLC stage IIIb HCC?

The trial evaluates hepatectomy combined with targeted apatinib and immunotherapeutic camrelizumab in a single-arm phase II design.

How often are participants followed during and after treatment?

Participants undergo follow-up every 2–3 months after treatment initiation to capture disease progression and adverse event incidence for at least 24 months after discontinuation.

What is the primary endpoint of the study?

The primary endpoint is patient mortality.

Sep 24, 2026

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