SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial.

作者：Jianming Xu, Yanqiao Zhang, Gang Wang, Weiqing Chen, Zhuang Li, Shanzhi Gu, Jinfang Zheng, Lei Han, Zujiang Yu, Hongmei Sun, Xiaoyong Wei, Ying Cheng, Lu Zheng, Hailan Lin, Bo Zhu, Guicheng Wu, Kaijian Lei, Wenlin Gai, Liangzhi Xie · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.4092 · 被引用次数：16 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Colorectal Cancer Treatments and Studies、Cancer Genomics and Diagnostics

4092 Background: Hepatocellular carcinoma (HCC) is a significant health concern in China, and it has been a leading cause of cancer-related deaths. Immunotherapy combined with anti-vascular growth therapy is the first recommended therapy. In this study, we evaluated the safety and efficacy of SCT-I10A (an anti-programmed death 1 [PD-1] monoclonal antibody) combined with SCT510 (a bevacizumab biosimilar) compared to sorafenib as the first-line treatment for advanced HCC. Methods: In this open-label, multicenter, phase 3 trial (NCT04560894) conducted in China, patients with advanced HCC who had not received prior system therapy were enrolled and randomly assigned (2:1) to receive SCT-I10A (200 mg every three weeks [Q3W]) plus SCT510 (a bevacizumab biosimilar, 15 mg/kg Q3W) or sorafenib (400 mg orally twice daily) until no clinical benefit or unacceptable toxicity. Randomization was stratified by ECOG performance status (0 vs. 1), baseline alpha-fetoprotein level (<400ng/ml vs. ≥400ng/ml), macrovascular invasion or extrahepatic metastasis (yes vs. no). The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) as assessed by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the full analysis set. Results: At the data cutoff for the interim analysis (November 2, 2023), a total of 346 patients were enrolled and received at least one dose (SCT-I10A plus SCT510 group, n=230;...