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

Gastric Cancer. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02704299
• Other study ID #: CBMG-TCM-GC-1.1
• Status: Not yet recruiting
• Phase: Phase 0
• First received: February 26, 2016
• Last updated: March 9, 2016
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: March 2016
• Source: Cellular Biomedicine Group Ltd.
• Contact: Jiafu / Ji, Doctor
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Safety:AE/SAE Efficacy:immunologic function;FPS

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer.
• Stomach Neoplasms

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival(PFS)	The primary objective is to assess progression free survival (PFS).	24months	No
Secondary	Incidences of adverse events or serious adverse events		24months	No