Efficacy and safety of donafenib plus transarterial chemoembolization and immunotherapy for hepatocellular carcinoma

doi:10.4251/wjgo.v17.i6.105170

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World Journal of Gastrointestinal Oncology

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World J Gastrointest Oncol. Jun 15, 2025; 17(6): 105170
Published online Jun 15, 2025. doi: 10.4251/wjgo.v17.i6.105170

Efficacy and safety of donafenib plus transarterial chemoembolization and immunotherapy for hepatocellular carcinoma

Zhi-Hao Yang, Si-Nan Liu, Fu-Ying Chu, Cheng Yang, Xiang Chen

Zhi-Hao Yang, Si-Nan Liu, Fu-Ying Chu, Xiang Chen, Department of Laboratory Medicine, Nantong First People’s Hospital and The Second Affiliated Hospital of Nantong University, Medical School of Nantong University, Nantong 226001, Jiangsu Province, China

Cheng Yang, Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, The Affiliated to Naval Medical University, Nantong 226001, Jiangsu Province, China

Co-first authors: Zhi-Hao Yang and Si-Nan Liu.

Co-corresponding authors: Cheng Yang and Xiang Chen.

Author contributions: Yang ZH and Liu SN jointly performed the experiments, analyzed and interpreted the data, organized editing for language and vocabulary, reviewed the article format, analyzed the tools and data, and wrote the paper. The two authors made crucial contributions to the completion of this project, and, therefore, are eligible to be co-first authors thereof. Chu FY contributed reagents, materials, analytical tools, and data. Yang C and Chen X conceived and designed the experiments and wrote the manuscript. This collaboration between Yang C and Chen X is crucial for the publication of this manuscript and other manuscripts still in preparation.

Institutional review board statement: This investigation was approved by the Ethics Committee of the First People’s Hospital of Nantong in 2023 under the ethical review number 2023KT197.

Informed consent statement: All the patients provided written informed consent before inclusion in the study.

Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.

Data sharing statement: No additional data are available.

Corresponding author: Xiang Chen, PhD, Department of Laboratory Medicine, Nantong First People’s Hospital and The Second Affiliated Hospital of Nantong University, Medical School of Nantong University, No. 666 Shengli Road, Nantong 226001, Jiangsu Province, China. ntchenx0520@163.com

Received: January 14, 2025
Revised: March 11, 2025
Accepted: April 18, 2025
Published online: June 15, 2025
Processing time: 151 Days and 4.3 Hours

Abstract

BACKGROUND

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related deaths worldwide and currently lacks effective treatment options. This is particularly true for advanced HCC, for which conventional therapies often lead to a poor prognosis.

AIM

To assess the safety and efficacy of transarterial chemoembolization (TACE) with donafenib and immune checkpoint inhibitors (ICIs) for unresectable HCC.

METHODS

We retrospectively assessed the data of patients with HCC who underwent TACE combined with donafenib and an ICI (tislelizumab or cedilimumab). Patients received oral donafenib daily for 2 weeks before TACE, followed by tislelizumab or cedilimumab 200 mg intravenously on day 1 of a 21-day therapeutic cycle. The primary endpoints were objective response rate, disease control rate, and duration of response according to the modified RECIST criteria. The secondary endpoint was presence of treatment-related adverse events (TRAEs).

RESULTS

The median follow-up was 7.8 months (95%CI: 5.0-11.8 months). The objective response rate was 60.0% (18/30), while the disease control rate was 93.3%. The median duration of response in confirmed responders was 6.6 months (95%CI: 1.3-12.9 months). The median progression-free survival was 11.8 months (95%CI: 8.3-15.4 months). More than half of the patients survived until the end of the study. Grade > 3 TRAEs occurred in 40% of the patients with no grade 5 TRAEs reported. The most common grade 3/4 TRAE was palmar-plantar erythrodysesthesia, a dermatologic condition characterized by painful redness and swelling of the palms and soles, with an incidence of 56.7%. No ICI-related adverse effects were observed.

CONCLUSION

TACE combined with donafenib and ICI is a promising and safe therapeutic regimen for unresectable HCC.

Keywords: Hepatocellular carcinoma; Donafenib; Transarterial chemoembolization; Immunotherapy; Therapy

Core Tip: Transarterial chemoembolization combined with donafenib and immune checkpoint inhibitors has been clinically applied in patients with unresectable hepatocellular carcinoma. This study assesses the safety and efficacy of this treatment strategy to better promote the adoption thereof in clinical practice.