[Translation] A multi-center, open-label, randomized controlled exploratory phase II clinical study to evaluate the efficacy and safety of autologous RAK cells in preventing high-risk recurrence after surgical radical resection of hepatocellular carcinoma
主要目的:评价自体RAK细胞静脉输注或自体RAK细胞静脉输注联合TACE治疗,对于根治性切除术后且存在高危复发风险的原发性肝细胞癌患者,预防复发方面的疗效。
次要目的:考察自体RAK细胞静脉输注或自体RAK细胞静脉输注联合TACE治疗的安全性。
探索性目的:免疫效应评价、潜在血清生物标志物、蛋白质组学、ctDNA分析,以探索高危复发患者的特征和/或分析自体RAK细胞注射液潜在的优势人群。
[Translation] The main purpose: To evaluate the curative effect of autologous RAK cell intravenous infusion or autologous RAK cell intravenous infusion combined with TACE in the prevention of recurrence in patients with primary hepatocellular carcinoma after radical resection and high risk of recurrence.
Secondary purpose: To investigate the safety of autologous RAK cell intravenous infusion or autologous RAK cell intravenous infusion combined with TACE therapy.
Exploratory purposes: evaluation of immune effects, potential serum biomarkers, proteomics, and ctDNA analysis to explore the characteristics of high-risk relapse patients and/or analyze the potential advantageous population of autologous RAK cell injection.