Back to resultsThe Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Primary Purpose
Gastric Cancer.
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Autologous T cells-Based Immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer.
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous T cells-Based Immunotherapy
Arm Description
Surgery Chemotherapy Autologous T cells-Based Immunotherapy
Outcomes
Primary Outcome Measures
Progression-Free-Survival(PFS)
The primary objective is to assess progression free survival (PFS).
Secondary Outcome Measures
Incidences of adverse events or serious adverse events
Full Information
NCT ID
NCT02704299
First Posted
February 26, 2016
Last Updated
March 9, 2016
Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT02704299
Brief Title
The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Official Title
A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
Peking University Cancer Hospital & Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer.
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous T cells-Based Immunotherapy
Arm Type
Experimental
Arm Description
Surgery Chemotherapy Autologous T cells-Based Immunotherapy
Intervention Type
Biological
Intervention Name(s)
Autologous T cells-Based Immunotherapy
Other Intervention Name(s)
TCM
Intervention Description
TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.
Primary Outcome Measure Information:
Title
Progression-Free-Survival(PFS)
Description
The primary objective is to assess progression free survival (PFS).
Time Frame
24months
Secondary Outcome Measure Information:
Title
Incidences of adverse events or serious adverse events
Time Frame
24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiafu / Ji, Doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
/ / /, /
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
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