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

• ClinicalTrials.gov Identifier: NCT02704299
• Recruitment Status: Unknown
• First Posted: March 10, 2016
• Last Update Posted: March 11, 2016
• Sponsor: Cellular Biomedicine Group Ltd.
• Collaborator: Beijing Cancer Hospital
• Information provided by (Responsible Party): Cellular Biomedicine Group Ltd.

Tracking Information

• First Submitted Date: February 26, 2016
• First Posted Date: March 10, 2016
• Last Update Posted Date: March 11, 2016
• Study Start Date: March 2016
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: March 9, 2016): Incidences of adverse events or serious adverse events [ Time Frame: 24months ]

Original Secondary Outcome Measures (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: 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.
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer.

Intervention

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

Experimental: Autologous T cells-Based Immunotherapy

Surgery Chemotherapy Autologous T cells-Based Immunotherapy

Intervention: Biological: Autologous T cells-Based Immunotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 4, 2016): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2018
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02704299
• Other Study ID Numbers: CBMG-TCM-GC-1.1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Cellular Biomedicine Group Ltd.
• Study Sponsor: Cellular Biomedicine Group Ltd.
• Collaborators: Beijing Cancer Hospital

Investigators

• Principal Investigator: / / /, /

• PRS Account: Cellular Biomedicine Group Ltd.
• Verification Date: March 2016