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

December 30, 2015 updated by: Second Military Medical University

A Controlled Clinic Trial of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Combination With Transcatheter Arterial Chemoembolization in Treating Patients With Advanced Hepatocellular Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
        • Principal Investigator:
          • Qijun Qian, PHD
        • Principal Investigator:
          • Huajun Jin, PHD
        • Principal Investigator:
          • Feng Shen, PHD
        • Principal Investigator:
          • Zengqiang Qu, PHD
        • Principal Investigator:
          • Qian Zhang, PHD
        • Sub-Investigator:
          • Yao Huang, PHD
        • Sub-Investigator:
          • Yan Sun, PHD
        • Sub-Investigator:
          • Fuping Zhou, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.
Procedure: TACE
lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.
Drug: lipiodol
lipiodol 10-20ml,hepatic arterial infusion
Drug: Mitomycin (MMC)
MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.
Drug: Epirubicin(EADM)
EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.
Experimental: DC-PMAT cells
After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.
Procedure: TACE
lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.
Drug: lipiodol
lipiodol 10-20ml,hepatic arterial infusion
Drug: Mitomycin (MMC)
MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.
Drug: Epirubicin(EADM)
EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.
Biological: Dendritic Cell
DC 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.
Other Names:
  • DC
Biological: Precision Multiple Antigen T Cell
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.
Other Names:
  • PMAT cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival
Time Frame: 2 years
2 years
Quality of life
Time Frame: 2 years
Quality of life core questionnaire will be used.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Military Medical University

Investigators

  • Study Chair: Feng Shen, PHD, Eastern Hepatobiliary Surgery Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (Estimate)

December 23, 2015

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2015-02-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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