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

Second Military Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recurrence Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma

Treatments: Drug: Epirubicin(EADM); Drug: Mitomycin (MMC); Biological: Precision Multiple Antigen T Cell; Drug: lipiodol; Procedure: TACE; Biological: Dendritic Cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02638857

EHBHKY2015-02-004

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18~65 years old, male or female
2. Signed informed consent
3. Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out.
4. The recurrence of HCC was found after the operation without distant metastasis.
5. The Eastern Cooperative Oncology Group (ECOG) score ≤2
6. Child-Pugh score of liver function ≤ 9
7. Routine blood meets the requirements.

Exclusion criteria

1. Expected Overall survival < 3 months
2. The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
3. Liver function is Childs Pugh C
4. Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
5. Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Transcatheter Arterial Chemoembolization

Sham Comparator group

Description:

Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.

Treatment:

Drug: Mitomycin (MMC)

Drug: Epirubicin(EADM)

Procedure: TACE

Drug: lipiodol

DC-PMAT cells

Experimental group

Description:

After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.

Treatment:

Drug: Mitomycin (MMC)

Biological: Dendritic Cell

Drug: Epirubicin(EADM)

Procedure: TACE

Biological: Precision Multiple Antigen T Cell

Drug: lipiodol