Neoadjuvant immune-checkpoint blockade therapy in combination with TACE for resectable hepatocellular carcinoma with high recurrence risk: A phase II, single-arm clinical trial (MORNING).

作者：Ming Kuang, Li Tan, Lixia Xu, Shunli Shen, Dongming Li, Yunpeng Hua, Shaoqiang Li, Li‐Jian Liang, Qiang He, Qi Zhou, Wenxuan Xie, Zebin Chen, Jian Wu, Jiaping Li, Wenzhe Fan, Wenquan Zhuang, Lili Chen, Shi‐Ting Feng, Sui Peng, Jiping Wang · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.e16304 · 被引用次数：1 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Ferroptosis and cancer prognosis、Cancer, Lipids, and Metabolism

e16304 Background: Prognoses for patients with hepatocellular carcinoma (HCC) remain suboptimal due to the high recurrence rates following curative intended hepatectomy. In this study, we evaluated the safety and efficacy of neoadjuvant Cadonilimab (a bi-specific antibody targeting PD-1 and CTLA-4) in combination with transarterial chemoembolization (TACE) for patients at high risk of recurrence. Methods: In this phase II, single-arm trial, resectable HCC (BCLC stage A/B) participants were enrolled. Patients should meet at least one of the following high-risk criteria: a) Multiple tumors or satellite lesions (≥2); b) tumor diameter > 5cm (single tumor); c) AFP ≥ 400 ug/L; d) Predicted to be positive by the Microvascular invasion prediction model of our center according to preoperative imaging. All patients received two cycles of Cadonilimab(10mg/kg, Q3W) following TACE treatment. After resection, patients received additional 12 months of Cadonilimab (10mg/kg, Q3W). The primary endpoint was the major pathological response(MPR, defined as ≥90% necrosis of the resected tumour),while the secondary endpoints include objective response rate (ORR), one-year recurrence rate and safety. Results: Until December 13th, 2024, a total of 30 patients were enrolled and underwent successful resection. Among the patients, 25(83.3%) were male, with the mean age of 54 years. Fourteen (46.7%) patients had multiple tumors, and 22(73.3%) had tumors larger than 5cm. Nineteen (63.3%) achieved MPR,...