Transarterial chemoembolization (TACE) combined with camrelizumab and apatinib versus TACE alone in the treatment of unresectable hepatocellular carcinoma eligible for embolization: A multicenter, open-label, randomized, phase 2 study (CAP-ACE).

作者：Haidong Zhu, Gao‐Jun Teng, Weijun Fan, Jiansong Ji, Wei-Zhu Yang, Chang Zhao, Ming Huang, Song Wang, Yuliang Li, Guoliang Shao, Hongtao Cheng, Yongyi Zeng, Wei‐Fu Lv, Hao Xu, Ligong Lu, Haibo Shao, Xuya Zhao, Shanzhi Gu, Hailan Lin, Wen‐Heng Zheng · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.4_suppl.lba522 · 被引用次数：13 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Liver physiology and pathology、Cancer Mechanisms and Therapy

LBA522 Background: Transarterial chemoembolization (TACE) has been established as a standard treatment for hepatocellular carcinoma (HCC) eligible for embolization. Combining immunotherapy and tyrosine kinase inhibitors (TKIs) with TACE can potentially enhance antitumor activity by activating the immune system and inhibiting tumor neovascularization. This study investigated whether the addition of camrelizumab and apatinib to TACE could bring better survival benefits. Methods: This open-label, randomized phase 2 study (NCT04559607) was conducted at 23 sites in China. Patients with unresectable HCC eligible for embolization were randomly assigned to receive either TACE combined with camrelizumab (200 mg once every 3 weeks) and apatinib (250 mg once daily; TACE-CA) or TACE alone. The stratification factors for randomization included vascular invasion (yes vs. no), prior use of TKIs (yes vs. no), and number of prior TACE (0 vs. 1-2). Prior immunotherapy was not allowed. The primary endpoint was progression-free survival (PFS) assessed by investigators according to the Response Evaluation Criteria In Cancer of the Liver (RECICL), analyzed in intention-to-treat population. Results: Between Dec 28, 2020 and Oct 29, 2023, 200 patients were randomized (100 in each group). Median age was 58.5 years (IQR, 51.5-65) and 57.0 years (IQR, 51-65.5) in the TACE-CA and TACE groups, respectively; most patients had Barcelona Clinic liver cancer (BCLC) stage B-C disease (86.0% and 86.0%). As of ...