NCT05738980招募中不适用
Prevention of Postoperative Recurrence of Hepatocellular Carcinoma by Blocking RAK Cells With Anti-TIM-3
Beijing Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- RFS
研究概览
简要总结
To compare the safety and efficacy of unmodified RAK cells and anti-TIM-3 blocked autologous RAK cells in preventing postoperative recurrence of HCC by postoperative TACE therapy combined with immune cell therapy.
详细描述
Research process:
Initial screening period (-7 to -1 days)
• Sign an informed consent form;
• Assign screening numbers;
• Assessment of eligibility for initial screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with HCC by histological examination; 4) According to China Liver Cancer Staging (CNLC) -- Guidelines for the Diagnosis and Treatment of primary liver Cancer of the National Health Commission of the People's Republic of China (2022 edition), patients with stage Ia and stage Ib ⅱA; 5) Undergoing radical resection of HCC; 6) For patients with hepatocellular carcinoma diagnosed by pathology after radical resection, the clinical and pathological characteristics meet one of the following conditions: A. tumor ≥5cm; B. Pathology suggested MVI (microvascular invasion); C. Pathology suggested satellite foci or sub-foci; D. Multiple tumors (number of tumors ≥2); E. AFP & GT; 20 mu g/L; F. Accompanied by hepatic capsule invasion; 7) ECOG score 0 or 1; Child-pugh liver function score A/B (≤7); 8) Neutrophil count ≥1.5×109/L, lymphocyte count ≥1.1×109/L, platelet count ≥80×109/L; Cardiac echocardiography showed that cardiac ejection fraction ≥50%, and 12-lead ECG showed no obvious abnormalities. Oxygen saturation ≥90%; Creatinine clearance rate CG formula ≥50 mL/min; ALT and AST 2.5 x ULN or less; Serum total bilirubin ≤1.5×ULN; 9) The estimated survival time is more than 6 months; 10) Fertile men or women with the possibility of becoming pregnant agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicide) during the trial and to continue contraception for 3 months after completion of treatment.
排除标准
- •Pregnant or lactating women; 2) Previous systemic treatment: cytotoxic chemotherapy drugs within 3 months, targeted drugs within 2 months, interferon and/or interleukin-2 within 3 months, and leukocyte raising drugs within 2 weeks; Have been treated with drugs that target immune regulatory points; 3) Have used immunosuppressive agents (e.g., azathioprine, 6-mercaptopurine, cyclosporine, tisirolimus, everolimus, rapamycin, etc.); Long-term use of corticosteroids; 4) History of thromboembolism within the last 3 months or high risk of pulmonary embolism; 5) Previous use of DC-CIK or CIK cells, autologous RAK/LAK cells or other adoptive immunotherapy; 6) A history of other malignant diseases in the last 5 years (except cured skin cancer and carcinoma in situ of the cervix); 7) Uncontrolled epilepsy, central nervous system diseases, cerebrovascular accidents, or accompanied by other uncontrolled diseases; A history of mental disorders; 8) Clinically severe heart disease (NYHA) grade II or more congestive heart failure or severe arrhythmias requiring medical intervention; 9) Interstitial lung disease ≥2 degrees; 10) Accompanied by fever or infection; 11) Autoimmune diseases, including uncontrolled hypothyroidism and hyperthyroidism; 12) HIV/AIDS or syphilis antibody positive; 13) Allergic to any interferon and interleukin-2 preparations; 14) Participating in other trials within 4 weeks before enrollment; 15) Poor compliance or conditions deemed inappropriate for study inclusion by the investigator.
研究组 & 干预措施
anti-Tim3-blocked RAK cells
Experimental
ubjects were randomly assigned to receive anti-TIM-3 blocked RAK cells or untreated RAK cells.
干预措施: Autologous RAK cells (Biological)
Unblocked RAK cells
Experimental
ubjects were randomly assigned to receive anti-TIM-3 blocked RAK cells or untreated RAK cells.
干预措施: Autologous RAK cells (Biological)
结局指标
主要结局
RFS
时间窗: two years
Recurrence-free survival (RFS) of postoperative TACE combined with TIM-3 block treated autologous RAK cells to prevent HCC recurrence
次要结局
- OS(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1Notch1Rg3TACEHepatocellular CarcinomaNCT02724358Eastern Hepatobiliary Surgery Hospital320
已完成
不适用
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE TherapyPrimary Hepatocellular CarcinomaNCT01828762Shanghai AbelZeta Ltd.8
Unknown
不适用
Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular CarcinomaRecurrenceHepatocellular CarcinomaNCT01924624The First Affiliated Hospital of Xiamen University140
Unknown
4 期
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal CancerColorectal CancerNCT00874406Fudan University100
尚未招募
3 期
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular InvasionHepatocellular CarcinomaNCT06089369Tongji Hospital360