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

Hongyu Pan, Liuyu Zhou, Zhuo Cheng, Jin Zhang, Ningjia Shen, Hongbin Ma, Yao Li, Riming Jin, Weiping Zhou, Dong Wu, Wen Sun () and Ruoyu Wang ()
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Hongyu Pan: Naval Medical University
Liuyu Zhou: Naval Medical University
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

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: 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.

Date: 2024
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DOI: 10.1038/s41467-024-53704-5

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