Impact of sintilimab plus anlotinib on progression-free survival in advanced unresectable hepatocellular carcinoma

doi:10.4251/wjgo.v18.i8.119966

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World Journal of Gastrointestinal Oncology

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1948-5204

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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Retrospective Cohort Study

Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastrointest Oncol. Aug 15, 2026; 18(8): 119966
Published online Aug 15, 2026. doi: 10.4251/wjgo.v18.i8.119966

Impact of sintilimab plus anlotinib on progression-free survival in advanced unresectable hepatocellular carcinoma

Cai Sheng, Huan Li

Cai Sheng, Huan Li, Department of Oncology, Xiangya Hospital, Central South University, Changsha 410000, Hunan Province, China

Cai Sheng, Department of Oncology, The Affiliated Changsha Central Hospital, University of South China, Changsha 410000, Hunan Province, China

Author contributions: Sheng C contributed to research design, data collection, data analysis, paper writing, research design, and funding application; Li H was responsible for reviewing and editing, communication coordination, ethical review, copyright and licensing, and follow-up; and all authors have read and approve the final manuscript.

AI contribution statement: During the writing process of this article, the author only used artificial intelligence tools (DeepSeek) to polish the language and text and optimize the fluency of expression. AI tools do not participate in any research data generation, results discussion, content analysis, and research conclusion formation. All output content generated by AI has been strictly reviewed, modified and finally confirmed by all authors, who bear full responsibility for the entire content of the article.

Institutional review board statement: The research was reviewed and approved by the Medical Ethics Review Committee of Xiangya Hospital of Central South University, No. 2025071087.

Informed consent statement: All research participants or their legal guardians provided written informed consent prior to study registration.

Conflict-of-interest statement: No conflict of interest is associated with this work.

STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.

Data sharing statement: No other data available.

Corresponding author: Huan Li, MD, Department of Oncology, Xiangya Hospital, Central South University, No. 87 Xiangya Road, Kaifu District, Changsha 410000, Hunan Province, China. 15211450392@163.com

Received: March 10, 2026
Revised: March 31, 2026
Accepted: May 6, 2026
Published online: August 15, 2026
Processing time: 146 Days and 11.6 Hours

Abstract

BACKGROUND

Hepatocellular carcinoma (HCC) has a poor prognosis in advanced unresectable stages, and sintilimab monotherapy has limited efficacy for it. Anlotinib monotherapy has demonstrated certain anti-tumor efficacy and manageable safety in the second-line and above treatment of advanced unresectable HCC, yet its single-agent effect is still limited for long-term disease control. Anti-angiogenic anlotinib synergizes with immunotherapy, but relevant clinical evidence for their combination in advanced unresectable HCC is insufficient. We hypothesized this combination could improve patients’ survival outcomes with acceptable safety.

AIM

To analyze sintilimab plus anlotinib’s impact on advanced unresectable HCC (uHCC) patients’ progression-free survival (PFS).

METHODS

Of 90 advanced uHCC patients were split into two groups (45 each): Sintilimab monotherapy vs its combination with anlotinib (sintilimab q3w, anlotinib 2w on/1w off). SPSS 26.0 was used for t-test, χ²-test, Kaplan-Meier and Cox regression analyses.

RESULTS

Baselines were comparable (P > 0.05). The combination group had longer median PFS (8.9 ± 0.4 months vs 4.7 ± 0.5 months, P < 0.001) and median overall survival (16.8 ± 1.2 vs months 10.3 ± 1.0 months, P < 0.001), higher objective response rate (48.9% vs 24.4%, P = 0.008) and disease control rate (86.7% vs 64.4%, P = 0.013). Tumor markers decreased more in the combination group (P < 0.05); adverse reactions showed no difference (P > 0.05). Cox analysis identified treatment regimen, Barcelona Clinical Stage of Liver Cancer stage and Eastern Cooperative Oncology Group score as independent PFS factors (P < 0.05).

CONCLUSION

Sintilimab plus anlotinib exerts better efficacy for advanced uHCC than monotherapy with similar safety.

Keywords: Sintilimab; Anlotinib; Hepatocellular carcinoma; Advanced unresectable disease; Progression-free survival

Core Tip: This retrospective study demonstrates that the combination of sintilimab (an anti-programmed death receptor 1 antibody) and anlotinib (a multi-target anti-angiogenic TKI) significantly improves progression-free survival, overall survival, and tumor response rates compared to sintilimab monotherapy in patients with advanced unresectable hepatocellular carcinoma, with a manageable safety profile.