NCT04538313Unknown1 期
Early Clinical Trials on Evaluating the Tolerance, Safety and Efficacy of Autologous TILs in High-risk Recurrent Primary Hepatocellular Carcinoma
CAR-T (Shanghai) Cell Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
Early clinical trials on evaluating the tolerance, safety and efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, gender unlimited;
- •Patients diagnosis of primary hepatocellular carcinoma by histopathology and/or cytology;
- •At the initial enrollment evaluation, patients were expected to accept radical resection of liver cancer and meet at least one of the following high-risk recurrence factors after surgery: ①There are 3 or more tumor lesions in the liver; ②The diameter of a single tumor lesion is >8cm; ③Existence macrovascular tumor thrombus; ④>5 MVI or MVI occurred in the distant paracancer tissues;
- •Before enrollment (after radical resection of liver cancer), imaging evaluation was performed to ensure that the tumor was completely removed (clear margin);
- •Must have at least 1 resectable lesion (diameter ≥2 cm);
- •ECOG score <2;
- •Child-Pugh score ≤7;
- •Hematology and organ function indicators should be met simultaneously: (1) White blood cell count ≥3.0E+9/ L, neutrophil count ≥1.5E+9/ L, platelet countPlatelet count ≥8.0E10/ L, hemoglobin ≥80g/L (2) Liver function: aspartate aminotransferase (AST)≤5 times normal value, alanine aminotransferase (ALT)≤5 times normal value, bilirubin ≤5 times normal value, serum albumin ≥28 g/L; (3) Renal function: creatinine (Cr)≤1.5 times normal limit, creatinine clearance ≥50 mL/min;
- •An estimated life expectancy of ≥3 months;
- •Participation in this clinical study voluntary, can cooperate with researchers to carry out research, and sign informed consent.
排除标准
- •Primary hepatocellular carcinoma (HCC) has recurred in the past, or has other types of liver cancer at the same time (such as intrahepatic cholangiocarcinoma, mixed type of liver cancer);
- •Have a history of high fever or severe infection within 2 weeks prior to pretreatment, or are expected to undergo systemic anti-infective therapy or systemic steroid therapy during this trial;
- •Hepatic encephalopathy occurred within 2 weeks before pretreatment;
- •Previous or screening with autoimmune liver disease;
- •Screening with moderate or higher peritoneal effusion;
- •Clear neurological/psychiatric symptoms are known to be associated with brain metastases and/or assessed by MMSE;
- •Anti-tumor therapy such as chemotherapeutic drugs, targeted drugs, radio frequency ablation or minimally invasive intervention was received within 4 weeks before pretreatment;
- •Have received or are expected to participate in this study within 4 weeks before pretreatment to receive TIL required focus radiotherapy, or tumor evaluation focus (target focus or non-target focus) radiotherapy, or radical radiotherapy;
- •Any toxic response resulting from previous anti-tumor treatment prior to pretreatment did not return to grade 1 or below (CTCAE5.0 version);
- •Previous history of organ / stem cell transplantation or expected to be involved in this trial for organ / stem cell transplantation;
- •Left ventricular ejection fraction (LVEF)<45% or New York Heart Association (NYHA)≥ grade 2;
- •Known or private HIV infection or syphilis infection;
- •The previous 3 years other system primary malignant tumor history (except skin basal cell carcinoma or cervical carcinoma in situ);
- •A known allergy to two or more non-homogeneous foods/drugs, or a known history of allergies to pre-treated drugs, including cyclophosphamide, fludarbin, interleukin;
- •Pregnant, lactating women or within one year of having a family plan;
- •Participated in other clinical trials within 3 months prior to screening;
- •Other circumstances that the researchers considered inappropriate to participate in the experiment.
研究组 & 干预措施
High dose group
Experimental
10^10 TIL
干预措施: Tumor infiltrating lymphocyte (Drug)
Low dose group
Experimental
10^9 TIL
干预措施: Tumor infiltrating lymphocyte (Drug)
Extension set
Experimental
The number of TIL is decided by dose escalation experiment.
干预措施: Tumor infiltrating lymphocyte (Drug)
结局指标
主要结局
DLT
时间窗: 24 months
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Progression-Free Survival
时间窗: 24 months
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
次要结局
- EQ-5D score(24 months)
- Overall Survival Overall Survival(24 months)
研究者
研究点 (1)
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