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<p>Postoperative recurrence significantly impacts long-term survival in patients with resectable hepatocellular carcinoma (HCC). In this single-arm, phase II trial (NCT04834986), 27 patients with resectable HCC at high recurrence risk received perioperative tislelizumab (anti-PD-1) plus lenvatinib (multi-kinase inhibitor). Co-primary endpoints were safety and feasibility. Secondary endpoints included objective response rate (ORR), 1-year and 2-year disease-free survival (DFS), median DFS, and pathologic complete response (pCR). Post-hoc exploratory machine learning analyses identified potential predictive factors. The regimen was feasible and generally well tolerated; grade 3 treatment-related adverse events occurred in 7.4%. ORR was 55.6%. Among 20 patients undergoing surgery, The Median DFS was 18.8 months (20.1-month follow-up), with 1- and 2-year DFS of 74.0% and 49.8%, and 20% achieved pCR. No unexpected safety signals were observed. The post-hoc machine learning model based on Tabular Prior Data Fitted Network, comprising six pretreatment hematological measures, demonstrated classification of candidate selection in the training set (area under the curve [AUC], accuracy [ACC], and average precision [AP], all 1.0) and the test set (AUC = 0.917, ACC = 0.778, AP = 0.966). In conclusion, tislelizumab-lenvatinib is a potential perioperative regimen for resectable HCC at high recurrence risk, showing preliminary efficacy and safety.</p>

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Perioperative tislelizumab plus lenvatinib treatment for resectable hepatocellular carcinoma at high risk of recurrence: single-arm phase II trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月8日

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  • Lu Chen,
  • Shujie Zhai,
  • Yayue Liu,
  • Wenchen Gong,
  • Feng Fang,
  • Qiang Wu,
  • Yunlong Cui,
  • Wei Zhang,
  • Huikai Li,
  • Yongmei Li,
  • Jihui Hao,
  • Tianqiang Song

摘要

Postoperative recurrence significantly impacts long-term survival in patients with resectable hepatocellular carcinoma (HCC). In this single-arm, phase II trial (NCT04834986), 27 patients with resectable HCC at high recurrence risk received perioperative tislelizumab (anti-PD-1) plus lenvatinib (multi-kinase inhibitor). Co-primary endpoints were safety and feasibility. Secondary endpoints included objective response rate (ORR), 1-year and 2-year disease-free survival (DFS), median DFS, and pathologic complete response (pCR). Post-hoc exploratory machine learning analyses identified potential predictive factors. The regimen was feasible and generally well tolerated; grade 3 treatment-related adverse events occurred in 7.4%. ORR was 55.6%. Among 20 patients undergoing surgery, The Median DFS was 18.8 months (20.1-month follow-up), with 1- and 2-year DFS of 74.0% and 49.8%, and 20% achieved pCR. No unexpected safety signals were observed. The post-hoc machine learning model based on Tabular Prior Data Fitted Network, comprising six pretreatment hematological measures, demonstrated classification of candidate selection in the training set (area under the curve [AUC], accuracy [ACC], and average precision [AP], all 1.0) and the test set (AUC = 0.917, ACC = 0.778, AP = 0.966). In conclusion, tislelizumab-lenvatinib is a potential perioperative regimen for resectable HCC at high recurrence risk, showing preliminary efficacy and safety.