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

NCT02704299 | Unknown Early Phase 1 DMC

• 1 other identifier: CBMG-TCM-GC-1.1
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastric Cancer.

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival(PFS)

  The primary objective is to assess progression free survival (PFS).

  24months

Secondary Outcomes (1)

• Incidences of adverse events or serious adverse events

  24months

Study Arms (1)

Autologous T cells-Based Immunotherapy

EXPERIMENTAL

Surgery Chemotherapy Autologous T cells-Based Immunotherapy

Biological: Autologous T cells-Based Immunotherapy

Interventions

Autologous T cells-Based Immunotherapy BIOLOGICAL

TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.

Also known as: TCM

Autologous T cells-Based Immunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• Peking University Cancer Hospital & Institute: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Jiafu / Ji, Doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 11, 2016

Record last verified: 2016-03