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

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, Jingtao Zhong and Lei Zhao ()
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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
Zhicheng Sun: Shandong Cancer Hospital Affiliated to Shandong First Medical University
Mingming Li: Shandong Cancer Hospital Affiliated to Shandong First Medical University
Yue Yang: Shandong Cancer Hospital Affiliated to Shandong First Medical University
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

Nature Communications, 2024, vol. 15, issue 1, 1-14

Abstract: 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.

Date: 2024
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DOI: 10.1038/s41467-024-47420-3

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