A Controlled Clinic Trial of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Combination With Transcatheter Arterial Chemoembolization in Treating Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Objectives:
The purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma.
Methods： This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial chemoembolization group and dendritic cell-precision multiple antigen T cells combined with transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
详细描述
A total of 60 patients may be enrolled over a period of 1-2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~65 years old, male or female
- •Signed informed consent
- •Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out.
- •The recurrence of HCC was found after the operation without distant metastasis.
- •The Eastern Cooperative Oncology Group (ECOG) score ≤2
- •Child-Pugh score of liver function ≤ 9
- •Routine blood meets the requirements.
排除标准
- •Expected Overall survival < 3 months
- •The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
- •Liver function is Childs Pugh C
- •Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
- •Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
- •Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
研究组 & 干预措施
DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
干预措施: lipiodol (Drug)
DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
干预措施: Dendritic Cell (Biological)
Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
干预措施: TACE (Procedure)
Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
干预措施: lipiodol (Drug)
Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
干预措施: Mitomycin (MMC) (Drug)
Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
干预措施: Epirubicin(EADM) (Drug)
DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
干预措施: TACE (Procedure)
DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
干预措施: Mitomycin (MMC) (Drug)
DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
干预措施: Epirubicin(EADM) (Drug)
DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
干预措施: Precision Multiple Antigen T Cell (Biological)
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Progress-free survival(2 years)
- Quality of life(2 years)