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

March 9, 2016 updated by: Cellular Biomedicine Group Ltd.

A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.

Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Safety:AE/SAE Efficacy:immunologic function;FPS

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jiafu / Ji, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous T cells-Based Immunotherapy
Surgery Chemotherapy Autologous T cells-Based Immunotherapy
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 Names:
  • TCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival(PFS)
Time Frame: 24months
The primary objective is to assess progression free survival (PFS).
24months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidences of adverse events or serious adverse events
Time Frame: 24months
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellular Biomedicine Group Ltd.

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: / / /, /

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBMG-TCM-GC-1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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