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已发表论文
肝细胞癌伴微血管侵犯切除术后辅助使用信迪利单抗联合或不联合抗血管内皮生长因子治疗：一项多中心回顾性研究
Authors Wang K, Xiang YJ , Yu HM, Cheng YQ, Zheng YT, Shan YF, Cheng SQ
Received 30 July 2025
Accepted for publication 26 November 2025
Published 16 December 2025 Volume 2025:12 Pages 2735—2744
DOI https://doi.org/10.2147/JHC.S557274
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Imam Waked
Kang Wang,1,2,* Yan-Jun Xiang,3,4,* Hong-Ming Yu,3 Yu-Qiang Cheng,3 Yi-Tao Zheng,5 Yun-Feng Shan,4 Shu-Qun Cheng1,3,4
1School of Medicine, Tongji University, Shanghai, People’s Republic of China; 2Department of Hepatic Surgery, The Oncology Center, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China; 3Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, People’s Republic of China; 4Department of Hepatobiliary Surgery, The First Affiliated Hospital, Wenzhou Medical University, Wenzhou, People’s Republic of China; 5Department of Hepatobiliary and Pancreatic Surgery, Ningbo No.2 Hospital, Ningbo, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Shu-Qun Cheng, School of Medicine, Tongji University, 1239 Siping Road, Shanghai, 200092, People’s Republic of China, Email chengshuqun@aliyun.com Yun-Feng Shan, Department of Hepatobiliary Surgery, The First Affiliated Hospital, Wenzhou Medical University, No. 2 Fuxue Lane, Wenzhou, Zhejiang, 325015, People’s Republic of China, Email shanyunfeng@wmu.edu.cn
Background: Patients with hepatocellular carcinoma (HCC) and microvascular invasion (MVI) face high post-resection relapse risk. Whether adjuvant PD-1 alone or with anti–vascular endothelial growth factor (anti-VEGF) improves outcomes remains uncertain.
Methods: Between 1 January 2022 and 1 January 2023, 170 consecutive patients from three Chinese centers were retrospectively reviewed. After resection, 69 received observation, 46 received intravenous sintilimab, and 55 received sintilimab plus either oral lenvatinib or intravenous bevacizumab biosimilar. Recurrence-free survival (RFS) was analyzed with Kaplan–Meier estimates and Cox models.
Results: Median follow-up was 24.7 months. Recurrence or death occurred in 42/69 (60.9%) observation patients, 19/46 (41.3%) sintilimab patients, and 23/55 (41.8%) combination patients. Median RFS was 16.1 months after observation, versus 29.5 months with sintilimab (hazard ratio=0.55, 95% confidence interval=0.32– 0.95; P = 0.033) and 30.5 months with sintilimab plus anti-VEGF therapy (hazard ratio=0.55, 95% confidence interval=0.33– 0.92; P = 0.023). One- and two-year RFS rates were 58.0% and 40.0% for observation, 73.9% and 66.6% for sintilimab, and 81.8% and 63.0% for combination therapy. Overall survival analysis is immature, median overall survival has not been reached in any group.
Conclusion: Adjuvant sintilimab, with or without anti-VEGF therapy, significantly prolonged RFS compared with surgery alone in patients with MVI-positive HCC. The magnitude of benefit was comparable between monotherapy and combination therapy, indicating that routine addition of anti-VEGF therapy may not be necessary for all patients.
Keywords: microvascular invasion, adjuvant therapy, immunotherapy, PD-1 inhibitor, lenvatinib, bevacizumab
1School of Medicine, Tongji University, Shanghai, People’s Republic of China; 2Department of Hepatic Surgery, The Oncology Center, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China; 3Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, People’s Republic of China; 4Department of Hepatobiliary Surgery, The First Affiliated Hospital, Wenzhou Medical University, Wenzhou, People’s Republic of China; 5Department of Hepatobiliary and Pancreatic Surgery, Ningbo No.2 Hospital, Ningbo, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Shu-Qun Cheng, School of Medicine, Tongji University, 1239 Siping Road, Shanghai, 200092, People’s Republic of China, Email chengshuqun@aliyun.com Yun-Feng Shan, Department of Hepatobiliary Surgery, The First Affiliated Hospital, Wenzhou Medical University, No. 2 Fuxue Lane, Wenzhou, Zhejiang, 325015, People’s Republic of China, Email shanyunfeng@wmu.edu.cn
Background: Patients with hepatocellular carcinoma (HCC) and microvascular invasion (MVI) face high post-resection relapse risk. Whether adjuvant PD-1 alone or with anti–vascular endothelial growth factor (anti-VEGF) improves outcomes remains uncertain.
Methods: Between 1 January 2022 and 1 January 2023, 170 consecutive patients from three Chinese centers were retrospectively reviewed. After resection, 69 received observation, 46 received intravenous sintilimab, and 55 received sintilimab plus either oral lenvatinib or intravenous bevacizumab biosimilar. Recurrence-free survival (RFS) was analyzed with Kaplan–Meier estimates and Cox models.
Results: Median follow-up was 24.7 months. Recurrence or death occurred in 42/69 (60.9%) observation patients, 19/46 (41.3%) sintilimab patients, and 23/55 (41.8%) combination patients. Median RFS was 16.1 months after observation, versus 29.5 months with sintilimab (hazard ratio=0.55, 95% confidence interval=0.32– 0.95; P = 0.033) and 30.5 months with sintilimab plus anti-VEGF therapy (hazard ratio=0.55, 95% confidence interval=0.33– 0.92; P = 0.023). One- and two-year RFS rates were 58.0% and 40.0% for observation, 73.9% and 66.6% for sintilimab, and 81.8% and 63.0% for combination therapy. Overall survival analysis is immature, median overall survival has not been reached in any group.
Conclusion: Adjuvant sintilimab, with or without anti-VEGF therapy, significantly prolonged RFS compared with surgery alone in patients with MVI-positive HCC. The magnitude of benefit was comparable between monotherapy and combination therapy, indicating that routine addition of anti-VEGF therapy may not be necessary for all patients.
Keywords: microvascular invasion, adjuvant therapy, immunotherapy, PD-1 inhibitor, lenvatinib, bevacizumab