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

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

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.

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

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