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The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.

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: NCT02704299
Recruitment Status : Unknown
Verified March 2016 by Cellular Biomedicine Group Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date March 11, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
Progression-Free-Survival(PFS) [ Time Frame: 24months ]
The primary objective is to assess progression free survival (PFS).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
Incidences of adverse events or serious adverse events [ Time Frame: 24months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
Determine safety of combination [ Time Frame: 24months ]
Incidences of adverse events or serious adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Official Title  ICMJE A Single-centered Clinical Trial of Surgery,Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Brief Summary Evaluate the feasibility ,safety and efficacy of Surgery,Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.
Detailed Description Safety:AE/SAE Efficacy:immunologic function;FPS
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer.
Intervention  ICMJE Biological: Autologous T cells-Based Immunotherapy
TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.
Other Name: TCM
Study Arms  ICMJE Experimental: Autologous T cells-Based Immunotherapy
Surgery Chemotherapy Autologous T cells-Based Immunotherapy
Intervention: Biological: Autologous T cells-Based Immunotherapy
Publications * Not Provided

*   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: March 4, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 to 80 years, males and females.
  • Subjects who understand and sign the consent form for this study.
  • The pathologically confirmed advanced gastric cancer T3、T4 or T2 and Metastasis in lymph nodes.
  • Subjects are surgical candidates.
  • No distant metastasis (M0) and No distant lymph node metastasis.
  • Expected survival time of at least 6 months.

Exclusion Criteria:

  • Subjects who do not sign the consent form for this study.
  • The subject has an allergic history of medicine or food.
  • The subject has uncontrolled or hard-to-control diseases of cardiovascular,liver,kidney or lung,endocrine system.
  • The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
  • The subject has an history of other malignant tumour.
  • The subject has history of alcoholism, drug abuse, or mental illness in the 12 years prior to this trial.
  • The subject has participated in any other clinical trial in the 3 months prior to this trial.
  • The subject is pregnant, lactating or planning to conceive within the next 24 months.
  • The subject has any other unsuitable or adverse condition to be determined by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704299
Other Study ID Numbers  ICMJE CBMG-TCM-GC-1.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cellular Biomedicine Group Ltd.
Study Sponsor  ICMJE Cellular Biomedicine Group Ltd.
Collaborators  ICMJE Beijing Cancer Hospital
Investigators  ICMJE
Principal Investigator: / / /, /
PRS Account Cellular Biomedicine Group Ltd.
Verification Date March 2016

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