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

作者：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, Ming Kuang · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.e16267 · 被引用次数：1 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Ferroptosis and cancer prognosis、Liver Disease Diagnosis and Treatment

e16267 Background: Prognoses of patients with hepatocellular carcinoma (HCC) remain unsatisfactory due to the high recurrence rate after curative hepatectomy. In this study, we investigated the safety and efficacy of neoadjuvant Cadonilimab (PD-1/CTLA-4, a bi-specific antibody) in combination with transarterial chemoembolization(TACE) for patients with high recurrence risk. Methods: For this phase II, single-centre, single-arm trial, resectable HCC (BCLC stage A/B) participants were enrolled, who 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 of the patients received two cycles of Cadonilimab(10mg/kg, Q3W) after TACE treatment. After resection, patients received additional 12 months of Cadonilimab(10mg/kg, Q3W) in the adjuvant setting. The primary end-point was the major pathologic response (MPR, defined as >90% necrosis of the resected tumour), the secondary endpoints are objective response rate (ORR), one-year recurrence rate and safety. Results: Between Apr 26th, 2023, and Jan 5th, 2024, 19 patients were enrolled, 84.2% of whom were male, with the mean age of 55. 9(47.4%) patients had more than one tumor and 13(68.4%) patients had tumors larger than 5cm. All patients received neoadjuvant TACE and at least one cycle of Cadonil...