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

Phase 1

• Conditions: Advanced Hepatocellular Carcinoma; Recurrence Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Drug: lipiodol; Biological: Dendritic Cell; Drug: Mitomycin (MMC); Drug: Epirubicin(EADM); Biological: Precision Multiple Antigen T Cell

• Registration Number: NCT02638857
• Lead Sponsor: Second Military Medical University

Brief 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.

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: 2015-12-09
• Study First Submitted QC: 2015-12-20
• Study First Posted: 2015-12-23
• 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), 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcatheter Arterial Chemoembolization	Mitomycin (MMC)	Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
Transcatheter Arterial Chemoembolization	TACE	Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
Transcatheter Arterial Chemoembolization	lipiodol	Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
Transcatheter Arterial Chemoembolization	Epirubicin(EADM)	Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
DC-PMAT cells	TACE	After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
DC-PMAT cells	Dendritic Cell	After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
DC-PMAT cells	lipiodol	After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
DC-PMAT cells	Mitomycin (MMC)	After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
DC-PMAT cells	Epirubicin(EADM)	After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
DC-PMAT cells	Precision Multiple Antigen T Cell	After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years

Secondary Outcome Measures

Name	Time	Method
Progress-free 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