Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638857
Recruitment Status : Unknown
Verified September 2015 by Second Military Medical University.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Recurrence Hepatocellular Carcinoma Advanced Hepatocellular Carcinoma Procedure: TACE Biological: Dendritic Cell Drug: lipiodol Drug: Mitomycin (MMC) Drug: Epirubicin(EADM) Biological: Precision Multiple Antigen T Cell Phase 1 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

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.

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 Name: DC

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: 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 Name: PMAT cell




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progress-free survival [ Time Frame: 2 years ]
  2. Quality of life [ Time Frame: 2 years ]
    Quality of life core questionnaire will be used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638857


Contacts
Layout table for location contacts
Contact: Qijun Qian, PHD +86-21-65580677 qianqj@sino-gene.cn
Contact: Huajun Jin, PHD +86-21-81875372 hj-jin@Hotmail.com

Locations
Layout table for location information
China
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, China, 200438
Contact: Huajun Jin, phd    +86-21-81875372    hj-jin@hotmail.com   
Principal Investigator: Feng Shen, PHD         
Principal Investigator: Qijun Qian, PHD         
Principal Investigator: Zengqiang Qu, PHD         
Principal Investigator: Qian Zhang, PHD         
Principal Investigator: Huajun Jin, PHD         
Sub-Investigator: Yao Huang, PHD         
Sub-Investigator: Yan Sun, PHD         
Sub-Investigator: Fuping Zhou, PHD         
Sponsors and Collaborators
Second Military Medical University
Investigators
Layout table for investigator information
Study Chair: Feng Shen, PHD Eastern Hepatobiliary Surgery Hospital
Publications:

Layout table for additonal information
Responsible Party: Second Military Medical University
ClinicalTrials.gov Identifier: NCT02638857    
Other Study ID Numbers: EHBHKY2015-02-004
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: September 2015
Keywords provided by Second Military Medical University:
Recurrence Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
Dendritic Cell -Precision Multiple Antigen T Cells
Transcatheter Arterial Chemoembolization
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Epirubicin
Mitomycins
Mitomycin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Nucleic Acid Synthesis Inhibitors