The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
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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
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Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer. | Biological: Autologous T cells-Based Immunotherapy | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-centered Clinical Trial of Surgery,Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer. |
Study Start Date : | March 2016 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | September 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Autologous T cells-Based Immunotherapy
Surgery Chemotherapy Autologous T cells-Based Immunotherapy
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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 |
- Progression-Free-Survival(PFS) [ Time Frame: 24months ]The primary objective is to assess progression free survival (PFS).
- Incidences of adverse events or serious adverse events [ Time Frame: 24months ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704299
Contact: Jiafu / Ji, Doctor |
Principal Investigator: | / / /, / |
Responsible Party: | Cellular Biomedicine Group Ltd. |
ClinicalTrials.gov Identifier: | NCT02704299 |
Other Study ID Numbers: |
CBMG-TCM-GC-1.1 |
First Posted: | March 10, 2016 Key Record Dates |
Last Update Posted: | March 11, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |