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

December 30, 2015 updated by: Second Military Medical University

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.

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 Locations

  • China
      • Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
        • Principal Investigator:
          • Qijun Qian, PHD
        • Principal Investigator:
          • Huajun Jin, PHD
        • Sub-Investigator:
          • Yao Huang, MD
        • Principal Investigator:
          • Weiping Zhou, PHD,MD
        • Principal Investigator:
          • Qian Zhang, PHD，MD
        • Principal Investigator:
          • Hui Liu, MD
        • Sub-Investigator:
          • Siyuan Fu, MD
        • Sub-Investigator:
          • Yan Sun, MD
        • Sub-Investigator:
          • Fuping Zhou, MD

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), 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 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
Active Comparator: Postoperative routine treatment
Postoperative routine treatment according to the hospitals local routines
Procedure: Postoperative routine treatment
Postoperative routine treatment according to the hospitals local routines
Experimental: 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.
Procedure: Postoperative routine treatment
Postoperative routine treatment according to the hospitals local routines
Biological: DC-PMAT treatment
Postoperative routine treatment according to the hospitals local routines; DC cell 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progress-free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall 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: Weiping Zhou, PHD,MD, 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 10, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 16, 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

  • EHBHKY2015-02-005

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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