The Study of Surgery,Chemotherapy and Autologous T Cells-... | NCT02704299

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

NCT02704299

Sponsor

Shanghai AbelZeta Ltd.

Status

Unknown status

Last Update Posted

Mar 11, 2016Estimated

Enrollment

36Estimated

Phase

Early Phase 1

Conditions

Gastric Cancer.

Interventions

Autologous T cells-Based Immunotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Feb 26, 2016

First Submission Date that Met QC Criteria

Mar 4, 2016

First Posted Date

Mar 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2016

Last Update Posted Date

Mar 11, 2016Estimated

Name	Class
Peking University Cancer Hospital & Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autologous T cells-Based Immunotherapy	Experimental	Surgery Chemotherapy Autologous T cells-Based Immunotherapy	Biological: Autologous T cells-Based Immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Incidences of adverse events or serious adverse events		24months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Jiafu / Ji, Doctor	Contact

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided