Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma

Second Military Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Cancer

Treatments: Biological: DC-PMAT treatment; Procedure: Postoperative routine treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02632188

EHBHKY2015-02-005

Details and patient eligibility

About

Objectives:

The purpose of this study is to evaluate the safety and efficacy of radical surgery combined with dendritic cell-precision multiple antigen T cells in reducing the recurrence and metastasis of liver cancer

Methods:

This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly divided into postoperative routine therapy group and dendritic cell-precision multiple antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision multiple antigen T cells 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), radical surgery was performed
4. The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out
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. Radical surgery was not performed or recurrence was found after operation
3. Liver function is Childs Pugh C
4. Had received other immunotherapy
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

Postoperative routine treatment

Active Comparator group

Description:

Postoperative routine treatment according to the hospitals local routines

Treatment:

Procedure: Postoperative routine treatment

DC-PMAT treatment

Experimental group

Description:

On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment.

Treatment:

Biological: DC-PMAT treatment

Procedure: Postoperative routine treatment