Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody

NCT ID: NCT03282435

Last Updated: 2017-09-14

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2023-01-31

Brief Summary

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to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CIK cells with PD-1 blocking

CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment

Group Type EXPERIMENTAL

CIK cells with PD-1 blocking

Intervention Type BIOLOGICAL

CIK cellular therapy with PD-1 blocking

standard lung cancer treament

Intervention Type OTHER

standard non-small cell lung cancer treatment: surgery, chemotherapy

CIK cells without PD-1 blocking

CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive

Group Type ACTIVE_COMPARATOR

standard lung cancer treament

Intervention Type OTHER

standard non-small cell lung cancer treatment: surgery, chemotherapy

CIK cells without PD-1 blocking

Intervention Type BIOLOGICAL

CIK cellular therapy without PD-1 blocking

Interventions

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CIK cells with PD-1 blocking

CIK cellular therapy with PD-1 blocking

Intervention Type BIOLOGICAL

standard lung cancer treament

standard non-small cell lung cancer treatment: surgery, chemotherapy

Intervention Type OTHER

CIK cells without PD-1 blocking

CIK cellular therapy without PD-1 blocking

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* non-small cell lung cancer;
* more than 50% tumor tissues positive with PD-L1;
* EGFR and ALK wild type
* no other tumors

Exclusion Criteria

* with systematic diseases shortening survival
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalian University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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xiaolin Yuan

Role: PRINCIPAL_INVESTIGATOR

Affiliated Zhongshan Hospital of Dalian University

Central Contacts

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haoren wang

Role: CONTACT

86-041162893507

Other Identifiers

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zsyy_zxsys2018-01

Identifier Type: -

Identifier Source: org_study_id

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