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Perioperative Tislelizumab plus intensity modulated radiotherapy in resectable hepatocellular carcinoma with macrovascular invasion: a phase II trial

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Listed:
  • Hongyu Pan

    (Naval Medical University)

  • Liuyu Zhou

    (Naval Medical University
    University of Shanghai for Science and Technology)

  • Zhuo Cheng

    (Naval Medical University)

  • Jin Zhang

    (Naval Medical University)

  • Ningjia Shen

    (Naval Medical University)

  • Hongbin Ma

    (Naval Medical University)

  • Yao Li

    (Naval Medical University)

  • Riming Jin

    (Naval Medical University)

  • Weiping Zhou

    (Naval Medical University)

  • Dong Wu

    (Naval Medical University)

  • Wen Sun

    (Naval Medical University)

  • Ruoyu Wang

    (Naval Medical University)

Abstract

Hepatocellular carcinoma (HCC) patients with macrovascular invasion (MVI) have dismal prognosis and there are no standard perioperative therapies. This phase 2 trial (ChiCTR2000036385) aimed to investigate the activity and safety of perioperative tislelizumab plus intensity modulated radiotherapy (IMRT) for resectable HCC with MVI. Thirty treatment-naïve patients with MVI received 3 cycles of tislelizumab intravenously (200 mg, every three weeks) and concurrent IMRT (45 Gray in 15 fractions). Primary endpoints were the overall response rate (ORR) and overall survival (OS). Secondary endpoints were the proportion of patients with a complete or major pathological response (pCR or MPR), recurrence-free survival (RFS) and safety. Of patients enrolled, 15 (50%) underwent curative surgery followed by adjuvant tislelizumab. The ORR was 30.0% (90% CI 16.6%-46.5%) and the median OS was 18.7 months. Of the 15 patients underwent surgical resection, 10 (66.7%) achieved pCR or MPR and 8 (53.3%) remained recurrence-free. The median RFS were not reached with a median follow-up of 21.77 months (95% CI 12.50-31.03) post-surgery. 4 (13.3%) patients experienced grade 3 treatment-related adverse events. The most common events were thrombocytopenia, leukopenia, and anemia. The trial has met the pre-specified endpoints, and these results support further studies of perioperative immunotherapy plus radiotherapy in HCC.

Suggested Citation

  • Hongyu Pan & Liuyu Zhou & Zhuo Cheng & Jin Zhang & Ningjia Shen & Hongbin Ma & Yao Li & Riming Jin & Weiping Zhou & Dong Wu & Wen Sun & Ruoyu Wang, 2024. "Perioperative Tislelizumab plus intensity modulated radiotherapy in resectable hepatocellular carcinoma with macrovascular invasion: a phase II trial," Nature Communications, Nature, vol. 15(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-53704-5
    DOI: 10.1038/s41467-024-53704-5
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    References listed on IDEAS

    as
    1. Zhongchao Li & Jing Liu & Bo Zhang & Jinbo Yue & Xuetao Shi & Kai Cui & Zhaogang Liu & Zhibin Chang & Zhicheng Sun & Mingming Li & Yue Yang & Zhao Ma & Lei Li & Chengsheng Zhang & Pengfei Sun & Jingta, 2024. "Neoadjuvant tislelizumab plus stereotactic body radiotherapy and adjuvant tislelizumab in early-stage resectable hepatocellular carcinoma: the Notable-HCC phase 1b trial," Nature Communications, Nature, vol. 15(1), pages 1-14, December.
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