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<p>Immune checkpoint inhibitors plus targeted therapy remains the mainstay of treatment for advanced hepatocellular carcinoma (HCC), yet its efficacy is limited. This study aimed to evaluate the efficacy and safety of tislelizumab combined with anlotinib and radiotherapy as first-line therapy for advanced HCC. This was a single-arm, single-center, phase II clinical trial. A total of 45 patients with advanced HCC were enrolled and administered first-line therapy consisting of tislelizumab plus anlotinib combined with radiotherapy. Stratification was performed according to pretreatment portal vein tumor thrombus (PVTT) status, Barcelona Clinic Liver Cancer (BCLC) stage, and median biologically effective dose (BED) of the gross tumor volume (GTV). Treatment response was assessed using the modified Response Evaluation Criteria in Solid Tumors, and adverse events (AEs) were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profiles reflected by AEs. The median BED of the GTV was 47.9&#xa0;Gy (Gy). The ORR and DCR were 62.2% (28/45) and 75.6% (34/45), respectively. Median PFS and OS were 11.0 months (95% CI 1.444–14.081) and 26.7 months (95% CI 1.749–25.178), respectively. ORR and DCR were comparable across subgroups defined by PVTT status, BCLC stage, and BED level (all <i>p</i> &gt; 0.05). No significant differences in PFS or OS were observed among these subgroups (all <i>p</i> &gt; 0.05). Most AEs (82.2%, 37/45) were grade 1/2 and well tolerated. Grade 3/4 AEs occurred in 13.3% (6/45) of patients. No grade 5 events, radiation-induced liver disease, or treatment-related deaths were reported. Tislelizumab combined with anlotinib and radiotherapy demonstrates promising efficacy and acceptable safety as first-line treatment for advanced HCC. Clinical outcomes appear to be independent of PVTT status, BCLC stage, or radiation BED level.</p><p>Registration Number in the Chinese Clinical Trial Registry: ChiCTR2000039022 (10/13/2020). <a href="https://www.chictr.org.cn/index.html">https://www.chictr.org.cn/index.html</a>.</p>

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Effect and safety of tislelizumab combined with anlotinib and radiotherapy in advanced hepatocellular carcinoma: A single-arm, single-center, phase II clinical study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月28日

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  • Huaxi Fan,
  • Yuhong Liu,
  • Guishu Wu,
  • Mingyue Rao,
  • Jing Zhang,
  • Peipei Zhu,
  • Jianwen Zhang

摘要

Immune checkpoint inhibitors plus targeted therapy remains the mainstay of treatment for advanced hepatocellular carcinoma (HCC), yet its efficacy is limited. This study aimed to evaluate the efficacy and safety of tislelizumab combined with anlotinib and radiotherapy as first-line therapy for advanced HCC. This was a single-arm, single-center, phase II clinical trial. A total of 45 patients with advanced HCC were enrolled and administered first-line therapy consisting of tislelizumab plus anlotinib combined with radiotherapy. Stratification was performed according to pretreatment portal vein tumor thrombus (PVTT) status, Barcelona Clinic Liver Cancer (BCLC) stage, and median biologically effective dose (BED) of the gross tumor volume (GTV). Treatment response was assessed using the modified Response Evaluation Criteria in Solid Tumors, and adverse events (AEs) were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profiles reflected by AEs. The median BED of the GTV was 47.9 Gy (Gy). The ORR and DCR were 62.2% (28/45) and 75.6% (34/45), respectively. Median PFS and OS were 11.0 months (95% CI 1.444–14.081) and 26.7 months (95% CI 1.749–25.178), respectively. ORR and DCR were comparable across subgroups defined by PVTT status, BCLC stage, and BED level (all p > 0.05). No significant differences in PFS or OS were observed among these subgroups (all p > 0.05). Most AEs (82.2%, 37/45) were grade 1/2 and well tolerated. Grade 3/4 AEs occurred in 13.3% (6/45) of patients. No grade 5 events, radiation-induced liver disease, or treatment-related deaths were reported. Tislelizumab combined with anlotinib and radiotherapy demonstrates promising efficacy and acceptable safety as first-line treatment for advanced HCC. Clinical outcomes appear to be independent of PVTT status, BCLC stage, or radiation BED level.

Registration Number in the Chinese Clinical Trial Registry: ChiCTR2000039022 (10/13/2020). https://www.chictr.org.cn/index.html.