DC Vaccine Combined With CIK Cells in Patients With Esoph... | NCT02693236

Studies
DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

NCT02693236

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Status

Unknown status

Last Update Posted

Feb 26, 2016Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Esophagus Cancer

Interventions

adenovirus-transfected autologous DC vaccine plus CIK cells

Countries

China

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

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Aug 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Feb 23, 2016

First Submission Date that Met QC Criteria

Feb 23, 2016

First Posted Date

Feb 26, 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

Feb 23, 2016

Last Update Posted Date

Feb 26, 2016Estimated

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

The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.

Detailed Description

Not provided

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adenovirus-transfected autologous DC vaccine plus CIK cells	Experimental		Biological: adenovirus-transfected autologous DC vaccine plus CIK cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
adenovirus-transfected autologous DC vaccine plus CIK cells	Biological		adenovirus-transfected autologous DC vaccine plus CIK cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
objective rate response (CR+PR) as measured by RECIST criteria		Time Frame: 4 weeks after DC/CIK treatment

Secondary Outcomes

Measure	Description	Time Frame
number of participants with adverse events		Time Frame: 3 days within DC/CIK treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histopathologically confirmed diagnosis of esophagus cancer
Age >18 years at time of consent
Received standardized treatment of Small-Cell Lung Cancer
Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
KPS (Karnofsky performance scale) >60
Patient's written informed consent
No severe viral or bacterial infections
Predicted survival >3 months

Exclusion Criteria:

Serious dysfunction of vital organs(heart, liver or kidney)
History of autoimmune diseases
Pregnant and breast-feeding patient
Active or chronic infectious diseases
History of allergy or hypersensitivity to study product excipients
Currently participating in another clinical trial
Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
Clinically relevant diseases or infections (HBV, HCV, HIV)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital to Academy of Military Medical Sciences		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal 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