Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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A total of 60 patients may be enrolled over a period of 1-2 years.

Official Title
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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

Conditions
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Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TACE
* Biological: Dendritic Cell
* Drug: lipiodol
* Drug: Mitomycin (MMC)
* Drug: Epirubicin(EADM)
* Biological: Precision Multiple Antigen T Cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Transcatheter Arterial Chemoembolization<br>Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles. | Procedure: TACE<br>* lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.<br>Drug: lipiodol<br>* lipiodol 10-20ml,hepatic arterial infusion<br>Drug: Mitomycin (MMC)<br>* MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.<br>Drug: Epirubicin(EADM)<br>* EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.<br>|
| Experimental: DC-PMAT cells<br>After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment. | Procedure: TACE<br>* lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.<br>Biological: Dendritic Cell<br>* DC suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62.<br>* Other names: DC;Drug: lipiodol<br>* lipiodol 10-20ml,hepatic arterial infusion<br>Drug: Mitomycin (MMC)<br>* MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.<br>Drug: Epirubicin(EADM)<br>* EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.<br>Biological: Precision Multiple Antigen T Cell<br>* PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.<br>* Other names: PMAT cell;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival |  | 2 years | 
| Quality of life | Quality of life core questionnaire will be used. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Dendritic Cell -Precision Multiple Antigen T Cells, Transcatheter Arterial Chemoembolization