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

Study Overview
=================
Brief Summary
-----------------
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.

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

Official Title
-----------------
A Controlled Clinic Trial to Survey the Outcome of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Treating Patients Underwent Radical Surgery for Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Procedure: Postoperative routine treatment
* Biological: DC-PMAT treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 65 years old, male or female Signed informed consent Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out 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 Radical surgery was not performed or recurrence was found after operation Liver function is Childs Pugh C Had received other immunotherapy 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postoperative routine treatment<br>Postoperative routine treatment according to the hospitals local routines | Procedure: Postoperative routine treatment<br>* Postoperative routine treatment according to the hospitals local routines<br>|
| Experimental: DC-PMAT treatment<br>On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment. | Procedure: Postoperative routine treatment<br>* Postoperative routine treatment according to the hospitals local routines<br>Biological: DC-PMAT treatment<br>* Postoperative routine treatment according to the hospitals local routines; DC cell 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. 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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrence, Metastasis, liver cancer