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

Phase 1

• Conditions: Liver Cancer
• Interventions: Procedure: Postoperative routine treatment; Biological: DC-PMAT treatment

• Registration Number: NCT02632188
• Lead Sponsor: Second Military Medical University

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.

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2016-01-01
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DC-PMAT treatment	Postoperative routine treatment	On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment.
Postoperative routine treatment	Postoperative routine treatment	Postoperative routine treatment according to the hospitals local routines
DC-PMAT treatment	DC-PMAT treatment	On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment.

Primary Outcome Measures

Name	Time	Method
Progress-free survival	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years
Quality of life	2 years	Quality of life core questionnaire will be used.

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, China