Nilvanstomig (ZG005), an anti-PD-1/TIGIT bispecific antibody, plus bevacizumab vs. sintilimab plus bevacizumab biosimilar as first-line therapy for advanced hepatocellular carcinoma: A randomized, multi-center, phase II trial.

作者：Hong Wu, Lianxin Liu, Sulai Liu, Xiaoli Chai, Jie Qiu, Yanqiao Zhang, Yu Zhang, Guicheng Wu, Y Zeng, Junye Wang, Yong Zha, Bing Huang, Feixiang Wu, Jun Zheng, 兰英华, Binhua Lv, Liqing Wu, Ruirui Xu, Anlan Zhang, Andrew X. Zhu · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.16_suppl.4014 · 研究领域：Monoclonal and Polyclonal Antibodies Research、CAR-T cell therapy research、Cancer Immunotherapy and Biomarkers

4014 Background: Checkpoint inhibitors combined with anti-angiogenic therapy represents one of the standard first-line therapies for advanced hepatocellular carcinoma (aHCC). Nilvanstomig (ZG005) is a recombinant humanized anti-PD-1/TIGIT bispecific antibody. By blocking both pathways, it can synergistically activate T cells and enhance the anti-tumor activity of NK cells. This study evaluated ZG005 plus bevacizumab vs. sintilimab plus IBI305 (a bevacizumab biosimilar) as first-line therapy for aHCC. Methods: In this randomized, open-label, multicenter, phase 2 trial conducted in China, patients with aHCC who had not previously received systemic treatment were randomly assigned (1:1:1) to receive ZG005 10 mg/kg plus bevacizumab 15 mg/kg (Arm A); ZG005 20 mg/kg plus bevacizumab 15 mg/kg (Arm B); or sintilimab 200 mg plus IBI305 15 mg/kg (Arm C). All treatments were administered intravenously every 3 weeks until disease progression or unacceptable toxicity. Randomization was stratified by baseline AFP level ( < 400 vs. ≥400 ng/mL), macrovascular invasion or extrahepatic metastasis (presence vs. absence). The primary endpoint was IRC-assessed PFS per RECIST v1.1, with key secondary endpoints including PFS per mRECIST, ORR and DCR by both criteria, and OS. Results: As of the data cutoff (Nov 25, 2025), 95 patients were enrolled and received at least one dose of treatment (Arm A, n = 31; Arm B, n = 32; Arm C, n = 32). Baseline characteristics were well-balanced across the treat...