肿瘤细胞治疗研究
英文原题：IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
这是一项 I 期注册临床试验，评估 CAR-T 细胞治疗肝细胞癌的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 3 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT06757881。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： 1. 男性或女性，年龄18–70岁； 2. 经组织病理学和/或细胞学确诊为晚期肝细胞癌，不适合手术或局部根治性治疗，且在至少一种标准系统治疗（包括分子靶向药或免疫检查点抑制剂）或介入治疗后出现肿瘤进展或无法耐受毒性； 3. 肝癌为中国肝癌分期（CNLC）Ⅱ或Ⅲ期，对应巴塞罗那临床肝癌分期（BCLC）B/C期，或符合《原发性肝癌诊疗规范（2022年版）》； 4. 预期生存期≥3个月； 5. 研究相关操作开始前已获知研究内容，自愿参加并能够签署知情同意书；同意且能够依照方案完成研究访视、影像学检查、实验室检查及其他研究程序； 6. 依从性良好，愿意且能够遵守所有研究程序并配合观察和随访。 排除标准： 1. 过去5年内或当前患有其他未治愈的恶性肿瘤，但临床认为可治愈的原位癌（如宫颈原位癌、皮肤基底细胞癌）除外； 2. 存在中枢神经系统转移或有临床意义的中枢神经系统疾病； 3. 妊娠或哺乳期； 4. 研究者认为存在任何不适合参加本临床研究的情况。
Inclusion Criteria: 1. Age 18-70 years old, male or female; 2. Patients with advanced hepatocellular carcinoma who are confirmed by histopathology and/or cytology to be ineligible for surgery and local radical therapy and who have developed tumor progression or toxicity intolerance following at least one standardized systemic therapy (including molecularly targeted agents and immune checkpoint inhibitors) or interventional therapy 3. Liver cancer subjects with stage II or III of China Liver Cancer Staging (CNLC) as defined by Barcelona Clinic Liver Cancer (BCLC) B/C level or the Code of Practice for Primary Liver Cancer Diagnosis and Treatment (2022 edition); 4. Expected survival ≥3 months 5. Before the start of the research related procedures, after explaining the research content, voluntarily participate and be able to sign the informed consent; Agree to and have the ability to follow study visits, imaging tests, laboratory tests, and other research procedures in the study plan; 6. Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up. Exclusion Criteria: 1. Have had other uncured malignancies within the past 5 years or at the same time, except for in situ cancers considered clinically curable, such as cervical carcinoma in situ and basal cell carcinoma of the skin 2. Central nervous system metastases and clinically significant central nervous system diseases 3. Pregnant or lactating women; 4. The investigator believes that the subjects have any circumstances that make them unfit to participate in this clinical study.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Number of participants with Dose Limited Toxicity · Within 28 days after the cell infusion；Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0 · From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins；Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) · From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins；Number of participants with treatment associated changes in clinically significant laboratory safety test values · From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
次要终点：Curative effect evaluation；Disease control rate (DCR)；Changes of serum IL1RAP level；Changes of copy number and absolute value of CAR-T cells targeting IL1RAP in peripheral blood；Progression-free survival (PFS)；Median PFS；Time to remission (TTR)；Duration of response after administration (DOR)
一项Ⅰ期研究，评估靶向IL1RAP的嵌合抗原受体T细胞治疗复发/难治性肝细胞癌。
A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
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