Personalized DC Vaccine for Lung Cancer

NCT ID: NCT02956551

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-06-01

Brief Summary

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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

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cell_therapy

tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times

Group Type EXPERIMENTAL

DC vaccine

Intervention Type BIOLOGICAL

subcutaneous administration

Interventions

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DC vaccine

subcutaneous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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Zhen-Yu Ding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhen-Yu Ding, Prof

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

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China West Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen-Yu Ding, Prof

Role: CONTACT

Facility Contacts

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Zhen-Yu Ding, Prof

Role: primary

00862885423571

Other Identifiers

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SKLB1608

Identifier Type: -

Identifier Source: org_study_id

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