肿瘤细胞治疗研究
英文原题：Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
⚠ 该试验的登记信息已有 37 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I 期注册临床试验，评估自体NK 细胞治疗肝细胞癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 3 例。试验地点：亚太其他 · 雅加达中区（共 1 个中心）。登记号：NCT06044506。
不限性别 · ≥ 20 Years 且 ≤ 60 Years
纳入标准： • 年龄20–60岁； • 肝细胞癌（HCC）分期为BCLC B期或C期； • Karnofsky体能状态（KPS）评分≥70； • 预计生存期超过3个月； • 指标符合要求：血小板≥80,000/µL，白细胞≥3000/µL，中性粒细胞≥2000，血红蛋白≥9 mg/dL，国际标准化比值（INR）0.8–1.5；肝功能适宜（胆红素<2，SGOT和SGPT<60 U/L）；肾功能适宜（血清肌酐<1.3，血清尿素<10）。 排除标准： • 拒绝参加研究； • 患有其他恶性肿瘤，包括非HCC肝脏恶性肿瘤或其他恶性肿瘤； • 患有高血压、严重冠心病、骨髓抑制、呼吸系统疾病或急慢性感染等其他情况； • 既往接受过移植或其他干细胞治疗。
Inclusion Criteria: * Patients aged 20-60 years old * Patients with Hepatocellular Carcinoma (HCC) staged as BCLC B and C * Karnofsky Performance Status (KPS) score ≥ 70 * Expected patient survival of more than three months * The following parameters are within the normal range: Platelet count ≥ 80,000/µL White blood cell count ≥ 3000/µL Neutrophil count ≥ 2000 Hemoglobin ≥ 9 mg/dL International Normalized Ratio (INR) 0.8-1.5 Adequate liver function (bilirubin \< 2, SGOT and SGPT \< 60 U/L) Adequate kidney function (serum creatinine \< 1.3, serum urea \< 10) Exclusion Criteria: * Refusing to participate in the study * Afflicted by other malignancies, whether non-HCC liver or other malignancies * Patients are affected by other conditions such as hypertension, severe coronary disease, myelosuppression, respiratory disorders, and acute or chronic infections * Patients who have previously undergone transplantation and received other stem cell therapies
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：Optimal treatment dosage · To evaluate the safety of autologous NK cell infusion and discover dose-limiting toxicities (DLT). This evaluation will determine the recommended dosage for the next trial phase. · Start of infusion of Autologous NK cells (Day 0) until up to 6 months
次要终点：Tumor Shrinkage；Immunological Responses；Hematology Profile；Progression-free survival
剂型：自体自然杀伤（NK）细胞。采集患者自身的细胞后再回输给患者。 剂量：根据患者身体状况和治疗反应确定，并为每位患者制定个体化剂量。 给药方式：静脉给药。 疗程：治疗时长根据患者反应和医学评估而定；全面评估疗效及潜在影响可能需要数周。
这项I期临床试验采用自然杀伤（NK）细胞治疗Child-Pugh A级、巴塞罗那临床肝癌分期（BCLC）B期或C期肝癌患者，旨在确定适宜剂量、观察不良反应并计算无进展生存期中位数。目标人群为所有肝癌患者；实际研究样本为2022年5月至12月在Cipto Mangunkusumo医院（RSCM）接受治疗并符合入组标准的患者。计划纳入2–3例接受自体NK细胞治疗的患者。NK细胞分离遵循Miltenyi Biotec指南。
This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.
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