Personalized DC Vaccine for Lung Cancer | NCT02956551

Studies
Personalized DC Vaccine for Lung Cancer

NCT02956551

Sponsor

Sichuan University

Status

Unknown status

Last Update Posted

May 31, 2018Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DC vaccine

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

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2016Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Nov 1, 2016

First Submission Date that Met QC Criteria

Nov 3, 2016

First Posted Date

Nov 7, 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

May 29, 2018

Last Update Posted Date

May 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.

Detailed Description

Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cell_therapy	Experimental	tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times	Biological: DC vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DC vaccine	Biological	subcutaneous administration	cell_therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 months after the last administration of cells

Secondary Outcomes

Measure	Description	Time Frame
objective response rate	Number of participants with objective responses as assayed by RECIST 1.1	through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathologically confirmed non-small cell lung cancer
failed in previous standard chemotherapy and targeted therapy
anticipated life time > 3month
Karnofsky performance status 0-1
rehabilitate from previous therapy
adequate organ functions

Exclusion Criteria:

mixed histological types
tumor emergency
abnormal coagulation condition
contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
concomitant tumors
immunological co-morbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhen-Yu Ding, Prof	Contact			dingzhenyu@scu.edu.cn

Overall Officials

Name	Affiliation	Role
Zhen-Yu Ding, Prof	Sichuan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China West Hospital	Recruiting	Chengdu	Sichuan	610000	China

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
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000706173	lentiviral minigene vaccine of COVID-19 coronavirus

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided