Back to resultsRadical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
Primary Purpose
Liver Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Postoperative routine treatment
DC-PMAT treatment
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Recurrence, Metastasis, liver cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18~65 years old, male or female
- Signed informed consent
- Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed
- The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out
- The Eastern Cooperative Oncology Group (ECOG) score ≤2
- Child-Pugh score of liver function ≤ 9
- Routine blood meets the requirements
Exclusion Criteria:
- Expected Overall survival < 3 months
- Radical surgery was not performed or recurrence was found after operation
- Liver function is Childs Pugh C
- Had received other immunotherapy
- Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements
Sites / Locations
- Eastern Hepatobiliary Surgery HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Postoperative routine treatment
DC-PMAT treatment
Arm Description
Postoperative routine treatment according to the hospitals local routines
On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment.
Outcomes
Primary Outcome Measures
Progress-free survival
Secondary Outcome Measures
Overall survival
Quality of life
Quality of life core questionnaire will be used.
Full Information
NCT ID
NCT02632188
First Posted
December 10, 2015
Last Updated
December 30, 2015
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02632188
Brief Title
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Military Medical University
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
A total of 60 patients may be enrolled over a period of 1-2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Recurrence, Metastasis, liver cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postoperative routine treatment
Arm Type
Active Comparator
Arm Description
Postoperative routine treatment according to the hospitals local routines
Arm Title
DC-PMAT treatment
Arm Type
Experimental
Arm Description
On the basis of postoperative routine treatment, patients will receive 3 cycles of dendritic cell-precision multiple antigen T (DC-PMAT) cells treatment.
Intervention Type
Procedure
Intervention Name(s)
Postoperative routine treatment
Intervention Description
Postoperative routine treatment according to the hospitals local routines
Intervention Type
Biological
Intervention Name(s)
DC-PMAT treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progress-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Title
Quality of life
Description
Quality of life core questionnaire will be used.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18~65 years old, male or female
Signed informed consent
Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed
The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out
The Eastern Cooperative Oncology Group (ECOG) score ≤2
Child-Pugh score of liver function ≤ 9
Routine blood meets the requirements
Exclusion Criteria:
Expected Overall survival < 3 months
Radical surgery was not performed or recurrence was found after operation
Liver function is Childs Pugh C
Had received other immunotherapy
Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
Unable or unwilling to provide informed consent, or fail to comply with the test requirements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qijun Qian, PHD
Phone
+86-21-65580677
Email
qianqj@sino-gene.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Zhou, PHD,MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Weiping Zhou, PHD,MD
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
First Name & Middle Initial & Last Name & Degree
Qian Zhang, PHD，MD
First Name & Middle Initial & Last Name & Degree
Hui Liu, MD
First Name & Middle Initial & Last Name & Degree
Siyuan Fu, MD
First Name & Middle Initial & Last Name & Degree
Yan Sun, MD
First Name & Middle Initial & Last Name & Degree
Fuping Zhou, MD
First Name & Middle Initial & Last Name & Degree
Yao Huang, MD
12. IPD Sharing Statement
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Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
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