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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Military Medical University
• Treatments: Epirubicin; Ethiodized Oil; Mitomycin; Mitomycins

Criteria

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.