肿瘤细胞治疗研究
英文原题：The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
这是一项 II 期注册临床试验，评估细胞治疗用于胃癌、多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 90 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT07212933。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： 1. 自愿参加研究并签署知情同意书。 2. 年龄≥18岁且≤70岁。 3. 胃镜病理或影像学（增强CT/PET-CT）确诊IV期胃癌或胃食管结合部腺癌（cT任意、N任意、M1）。转移部位包括但不限于肝、腹膜、肺、胰腺、大网膜及腹膜后淋巴结等。 4. 既往一线抗肿瘤治疗后失败或疾病进展（包括晚期胃癌一线、二线化疗、靶向治疗和免疫治疗无效）。 5. 有可测量实体瘤（疗效评价按RECIST 1.1）；治疗前28天内须进行CT或MRI肿瘤评估。 6. ECOG体能状态评分0至3。 7. 预期生存期≥1个月。 8. 能够理解研究程序，并同意参加研究及提供书面知情同意。 排除标准： 1. 同时患有其他类型的恶性肿瘤。 2. 患有严重心、肺或脑部疾病。 3. 预期生存期<1个月。 4. 实验室检查提示不适合接受抗肿瘤生物治疗： • 中度至重度骨髓抑制：血红蛋白<80 g/L、白细胞<2.0×10^9/L、ANC<1.0×10^9/L或血小板<50×10^9/L。 • 肝功能显著下降（Child-Pugh C级）。 • 严重肾功能不全（CKD III期及以上）。 • 严重凝血功能障碍（INR≥1.5或APTT>正常值上限的1.5倍）。
Inclusion Criteria: * 1\. Subjects voluntarily join this study and sign the informed consent form. 2. Age ≥18 years and ≤70 years. 3. Confirmed by gastroscopic pathology or imaging (enhanced CT/PET-CT) as Stage IV gastric cancer or gastroesophageal junction adenocarcinoma (cTanyNanyM1). Metastatic sites include but are not limited to: liver, peritoneum, lungs, pancreas, greater omentum, retroperitoneal lymph nodes, etc. 4\. Failure or disease progression after prior frontline anti-tumor therapy (including ineffective first- and second-line chemotherapy, targeted therapy, and immunotherapy for advanced gastric cancer). 5\. Have measurable solid tumors (efficacy evaluation standard: RECIST 1.1); tumor assessment via CT scan or MRI must be performed within 28 days before treatment. 6\. Physical performance status ECOG 0-3. 7. Expected lifespan ≥1 month. 8. Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent. Exclusion Criteria: * 1\. Concurrent other types of malignancy. 2. Severe cardiac, pulmonary, or cerebral system diseases. 3. Expected survival \<1 month. 4. Laboratory investigations indicating unsuitability for receiving anti-tumor biotherapy: 1. Moderate to severe bone marrow suppression: (HGB \<80 g/L; WBC \<2.0×10⁹/L; ANC \<1.0×10⁹/L; PLT \<50×10⁹/L). 2. Significantly decreased liver function (Child-Pugh Grade C). 3. Severe renal insufficiency (CKD Stage III and above). 4. Severe coagulation dysfunction (INR ≥1.5 or APTT \>1.5 × ULN).
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：Progression-free survival · Progression-Free Survival (PFS) is the length of time during and after treatment that a patient's cancer does not get worse. It measures how long the disease remains stable or in remission. · one-year
次要终点：Overall Survival；Objective Response Rate (ORR)；Time to Progression (TTP)
RAK细胞与TAS-102联合治疗。
单用TAS-102。
本项目采用前瞻性、双盲、随机对照试验方法，比较人脐带血RAK细胞治疗晚期胃癌的安全性和生存结局。首先通过剂量递增试验确定RAK细胞治疗晚期胃癌患者的最大耐受剂量（MTD），随后比较RAK治疗组与对照组的总生存期（OS）、无进展生存期（PFS）和不良事件发生率。本研究旨在探索一线治疗失败的复发或转移性胃癌生物治疗的疗效和安全性，为大规模多中心临床研究奠定基础并提供依据。
This project employs a prospective, double-blind, randomized controlled trial methodology to comparatively analyze the safety and survival outcomes of human umbilical cord blood RAK cells applied in advanced gastric cancer. Firstly, the maximum tolerated dose (MTD) of RAK cell therapy for patients with advanced gastric cancer will be determined through a dose-escalation trial. Subsequently, the overall survival (OS), progression-free survival (PFS), and incidence of adverse events will be compared between the RAK treatment group and the control group. This aims to explore the efficacy and safety of biotherapy for recurrent or metastatic gastric cancer where frontline therapy has failed, thereby laying the foundation and providing evidence for large-scale, multi-center clinical studies.
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