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Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

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: NCT02632201
Recruitment Status : Unknown
Verified September 2015 by Second Military Medical University.
Recruitment status was:  Recruiting
First Posted : December 16, 2015
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Second Military Medical University

Tracking Information
First Submitted Date  ICMJE December 13, 2015
First Posted Date  ICMJE December 16, 2015
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
Overall survival [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2015)
  • Progress-free survival [ Time Frame: 2 years ]
  • Quality of life [ Time Frame: 2 years ]
    Quality of life core questionnaire will be used.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • Progress-free survival [ Time Frame: 2 years ]
  • Quality of life [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis
Official Title  ICMJE A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Human Epidermal Growth Factor Receptor-2 (HER2) in Treating Patients With HER2-Positive Advanced Gastric Cancer With Liver Metastasis
Brief Summary

Objectives:

The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.

Methods:

This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment 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 40 patients may be enrolled over a period of 1-2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Metastasis
  • Gastric Cancer
Intervention  ICMJE
  • Biological: PIK-HER2
    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. PIK-HER2 cell suspension (1-6×109 PIK-HER2 + 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.
  • Biological: DC-PMAT
    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.
Study Arms  ICMJE
  • Experimental: PIK-HER2 cells
    PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods.
    Intervention: Biological: PIK-HER2
  • Active Comparator: DC-PMAT
    DC-PMAT treatment will be performed every 3 weeks with a total of three periods.
    Intervention: Biological: DC-PMAT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 15, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18~65 years old, male or female
  2. Life expectancy > 6 months
  3. Eastern Cooperative Oncology Group (ECOG) score: 0-2
  4. The stomach or gastroesophageal junction carcinoma with hepatic metastasis
  5. Adenocarcinoma
  6. The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels
  7. Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL
  8. Blood routine conforms to the requirements of the blood sampling
  9. Signed informed consent
  10. Patients with fertility are willing to use contraceptive method.

Exclusion Criteria:

  1. Expected Overall survival < 6 months
  2. Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc.
  3. Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L
  4. Without signed informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02632201
Other Study ID Numbers  ICMJE EHBHKY2015-02-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Military Medical University
Study Sponsor  ICMJE Second Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Qijun Qian, PHD Eastern Hepatobiliary Surgery Hospital
PRS Account Second Military Medical University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP