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Neoadjuvant tislelizumab plus stereotactic body radiotherapy and adjuvant tislelizumab in early-stage resectable hepatocellular carcinoma: the Notable-HCC phase 1b trial

Author

Listed:
  • Zhongchao Li

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Jing Liu

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Bo Zhang

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Jinbo Yue

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Xuetao Shi

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Kai Cui

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Zhaogang Liu

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Zhibin Chang

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University
    Shandong First Medical University and Shandong Academy of Medical Sciences)

  • Zhicheng Sun

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University
    Shandong First Medical University and Shandong Academy of Medical Sciences)

  • Mingming Li

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University
    Shandong First Medical University and Shandong Academy of Medical Sciences)

  • Yue Yang

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University
    Shandong First Medical University and Shandong Academy of Medical Sciences)

  • Zhao Ma

    (The Fourth People’s Hospital of Jinan)

  • Lei Li

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Chengsheng Zhang

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Pengfei Sun

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Jingtao Zhong

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University)

  • Lei Zhao

    (Shandong Cancer Hospital Affiliated to Shandong First Medical University
    Shandong First Medical University and Shandong Academy of Medical Sciences
    The Affiliated Cancer Hospital of Xinjiang Medical University)

Abstract

Notable-HCC (NCT05185531) is a phase 1b trial, aiming to evaluate the safety and preliminary effectiveness of neoadjuvant PD-1 blockade plus stereotactic body radiotherapy (SBRT) in early-stage resectable hepatocellular carcinoma (HCC). Twenty patients with HCC of BCLC stage 0-A received 3 $$\times $$ × Gy SBRT and two cycles of tislelizumab, an anti-PD-1 monoclonal antibody before the curative HCC resection. Primary endpoints were the surgery delay, radiographic and pathological tumor response after the neoadjuvant therapy, safety and tolerability. During the neoadjuvant therapy, treatment-related adverse events (TRAEs) of grade 1-2 occurred in all 20 patients (100%), eight patients (40%) had grade 3 TRAEs, no grade 4 to 5 TRAE occurred, and all resolved without corticosteroids treatment. Per mRECIST, the objective response rate was 63.2% (12/19), with 3 complete response; the disease control rate was 100%. Two (10.5%) patients achieved complete pathological response. No surgery delay occurred. The neoadjuvant therapy did not increase the surgical difficulty or the incidence of complications. Secondary endpoints of disease-free survival and overall survival were not mature at the time of the analysis. Our pilot trial shows that neoadjuvant therapy with anti-PD-1 + SBRT is safe and promotes tumor responses in early-stage resectable HCC.

Suggested Citation

  • 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.
  • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-47420-3
    DOI: 10.1038/s41467-024-47420-3
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