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Cancers
Special Issues
Decision-Making Biomarkers in the Treatment of Hepatocellular Carcinoma
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Decision-Making Biomarkers in the Treatment of Hepatocellular Carcinoma

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Cancer Biomarkers".

Deadline for manuscript submissions: 30 September 2026 | Viewed by 1190

Special Issue Editors

Dr. Norihiro Imai

E-Mail Website
Guest Editor
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
Interests: hepatocellular carcinoma; alcohol-associated liver disease; metabolic dysfunction-associated steatotic liver disease
Dr. Dongming Liu

E-Mail Website
Guest Editor
Department of Hepatobiliary Cancer, Liver Cancer Research Center, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, National Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin, China
Interests: hepatocellular carcinoma; neoadjuvant therapy; conversion therapy; surgical treatment

Special Issue Information

Dear Colleagues,

In recent years, significant progress has been made in the treatment of hepatocellular carcinoma (HCC). With the introduction of various therapeutic options, selecting the optimal treatment strategy for each patient has become increasingly important. In drug therapy, the advent of combination immunotherapy has transformed the treatment paradigm for advanced HCC, steadily improving patient prognosis. However, new challenges, such as immune-related adverse events, have also emerged. In surgical treatment, “conversion therapy” has become a viable option for patients with advanced HCC who respond to drug therapy. Additionally, the concept of “borderline resectable” disease has been proposed. However, there is still insufficient evidence to determine whether conversion surgery improves long-term prognosis. This Special Issue aims to present the latest research findings, from basic science to clinical applications. Topics include the prediction of disease progression using research biomarkers, the evaluation of relapse risk, and prognostic biomarkers, alongside established clinical tools such as blood biochemistry and imaging.

Dr. Norihiro Imai
Dr. Dongming Liu
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Cancers is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • hepatocellular carcinoma
  • borderline resectable
  • conversion therapy
  • neoadjuvant therapy
  • immunotherapy
  • immune-related adverse event
  • molecular-targeted agent

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Published Papers (3 papers)

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Research

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15 pages, 705 KB  
Article
Hepatic Arterial Infusion Chemotherapy with Serplulimab and the Bevacizumab Biosimilar HLX04 for Advanced Hepatocellular Carcinoma: A Prospective, Observational Phase II Clinical Trial
by Huikai Li, Tongguo Si, Rentao Li, Xiaojing Xie, Yang Liu, Linlin Fu, Yu Bai, Junchao Yao, Xihao Zhang, Mao Yang and Xiaofeng Mu
Cancers 2025, 17(19), 3235; https://doi.org/10.3390/cancers17193235 (registering DOI) - 5 Oct 2025
Abstract
Background/Objectives: Advanced hepatocellular carcinoma (HCC) presents limited treatment options; however, immunotherapy demonstrates encouraging outcomes and acceptable adverse reactions in advanced HCC. This study evaluates the efficacy and safety of combining serplulimab, the bevacizumab biosimilar HLX04, and hepatic arterial infusion chemotherapy (HAIC) as a [...] Read more.
Background/Objectives: Advanced hepatocellular carcinoma (HCC) presents limited treatment options; however, immunotherapy demonstrates encouraging outcomes and acceptable adverse reactions in advanced HCC. This study evaluates the efficacy and safety of combining serplulimab, the bevacizumab biosimilar HLX04, and hepatic arterial infusion chemotherapy (HAIC) as a first-line therapy. Methods: This prospective, observational, single-center phase II trial enrolled untreated HCC patients with Barcelona Clinic Liver Cancer (BCLC) stage C. All patients received serplulimab (4.5 mg/kg) and HLX04 (15.0 mg/kg) every 3 weeks, followed by the HAIC-FOLFOX regimen. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), and safety. Results: A total of 32 patients were enrolled. The best outcomes showed an ORR of 53.1%, including 17 partial responses (PR, 53.1%) and 12 stable diseases (SD, 37.5%), resulting in a DCR of 90.6%. Subgroup analysis showed a higher ORR in patients with a single lesion and those receiving ≥3 treatment cycles, with an ORR of 60.7% in the latter group. Additionally, five patients underwent successful hepatectomy after ≥3 treatment cycles, with postoperative pathology confirming extensive tumor necrosis. Kaplan–Meier analysis estimated PFS rates of 89.9% (95% CI: 79.5–100.0%) at 6 months and 70.8% (95% CI: 54.2–92.4%) at 12 months. No deaths related to adverse events (AEs) occurred; four (12.5%) patients experienced grade IV AEs and twelve (37.5%) patients experienced grade III AEs. Conclusions: Serplulimab, HLX04, and HAIC combined as a first-line treatment for advanced HCC have demonstrated promising efficacy, particularly in patients completing ≥3 cycles, with an acceptable safety profile. Further investigation in larger trials is required. Full article
(This article belongs to the Special Issue Decision-Making Biomarkers in the Treatment of Hepatocellular Carcinoma)
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11 pages, 1089 KB  
Article
CRAFITY and AFP/PIVKA-II Kinetics Predict Prognosis in Hepatocellular Carcinoma on Immunotherapy
by Shou-Wu Lee, Yi-Jie Huang, Ying-Cheng Lin, Hsin-Ju Tsai, Chia-Chang Chen, Chung-Hsin Chang, Teng-Yu Lee and Yen-Chun Peng
Cancers 2025, 17(18), 3058; https://doi.org/10.3390/cancers17183058 - 18 Sep 2025
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Abstract
Background: The CRAFITY score, integrating baseline C-reactive protein (CRP) and alpha-fetoprotein (AFP), has been validated as a prognostic biomarker in hepatocellular carcinoma (HCC) treated with immunotherapy, but many patients present with non-elevated AFP, limiting its accuracy. This study evaluated a composite model incorporating [...] Read more.
Background: The CRAFITY score, integrating baseline C-reactive protein (CRP) and alpha-fetoprotein (AFP), has been validated as a prognostic biomarker in hepatocellular carcinoma (HCC) treated with immunotherapy, but many patients present with non-elevated AFP, limiting its accuracy. This study evaluated a composite model incorporating the CRAFITY score with AFP/PIVKA-II kinetic changes. Methods: We retrospectively enrolled 69 patients with unresectable HCC (BCLC stage B/C) receiving immunotherapy between September 2021 and June 2023. Baseline CRP, AFP, and PIVKA-II, as well as 4-week changes, were recorded. The CRAFITY-100 RULE combined CRAFITY (0–2) with AFP/PIVKA-II kinetics (0–3), yielding three risk levels (I–III). Clinical outcomes included objective response (OR) and overall survival (OS). Results: Of the cohort, 10 (14.5%), 29 (42%), and 30 (43.5%) patients had CRAFITY scores 0, 1, and 2, respectively, but this score did not clearly stratify OS (median 24, 12, and 15 months; p = 0.267). In contrast, the CRAFITY-100 RULE classified 5 (7.3%), 35 (50.7%), and 29 (42%) patients into levels I–III, respectively, with significantly different survival (median OS 24, 15, and 7 months; p = 0.048). OR rates were lowest at level III (17%). Time-dependent ROC analysis confirmed superior discrimination of CRAFITY-100 RULE over CRAFITY scores at 6 months (AUROC 0.673 vs. 0.604) and 12 months (0.732 vs. 0.656). Conclusions: The CRAFITY-100 RULE provided clearer stratification and higher discrimination. This simple model integrating baseline and dynamic biomarkers may assist clinical decision-making in unresectable HCC treated with immunotherapy. Full article
(This article belongs to the Special Issue Decision-Making Biomarkers in the Treatment of Hepatocellular Carcinoma)
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Review

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29 pages, 719 KB  
Review
Decision-Making Biomarkers Guiding Therapeutic Strategies in Hepatocellular Carcinoma: From Prediction to Personalized Care
by Dongming Liu and Norihiro Imai
Cancers 2025, 17(19), 3105; https://doi.org/10.3390/cancers17193105 - 24 Sep 2025
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Abstract
Hepatocellular carcinoma (HCC) management has evolved remarkably with the advent of diverse therapeutic options, particularly systemic and surgical treatments. Combination immunotherapy has redefined the treatment paradigm for advanced HCC and contributed to improved patient outcomes. However, this brings forth challenges such as immune-related [...] Read more.
Hepatocellular carcinoma (HCC) management has evolved remarkably with the advent of diverse therapeutic options, particularly systemic and surgical treatments. Combination immunotherapy has redefined the treatment paradigm for advanced HCC and contributed to improved patient outcomes. However, this brings forth challenges such as immune-related adverse events that complicate decision-making. Surgical strategies have expanded with the emergence of conversion therapy and borderline resectability, offering curative potential for a broader patient population. However, robust evidence of their long-term efficacy is lacking. Therefore, decision-making biomarkers have gained prominence across treatment modalities. This review explores the current landscape of predictive, prognostic, and treatment-response biomarkers in HCC, from molecular and immune signatures to radiological and biochemical markers, highlighting their role in optimizing therapeutic strategies. By integrating recent advances in basic and translational research with clinical practice, we aim to outline a biomarker-driven framework for individualized care in HCC. Full article
(This article belongs to the Special Issue Decision-Making Biomarkers in the Treatment of Hepatocellular Carcinoma)
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