D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)

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/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-08-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).

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Detailed Description

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60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Conditions

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Lung Cancer Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D-CIK

After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.

Cisplatin

Intervention Type DRUG

Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.

D-CIK

Intervention Type BIOLOGICAL

8×10\^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

Chemotherapy

After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.

Cisplatin

Intervention Type DRUG

Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.

Interventions

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Gemcitabine

Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.

Intervention Type DRUG

Cisplatin

Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.

Intervention Type DRUG

D-CIK

8×10\^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

Intervention Type BIOLOGICAL

Other Intervention Names

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Gemzar cisplatinum

Eligibility Criteria

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Inclusion Criteria

* The patient who have singed the informed consent;
* Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
* Expected survival time is more than 2 month;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion Criteria

* Hemoglobin\<8.0 g/dL,White blood cell \<3 x 10\^9/L;Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Patients who are suffering from serious organ dysfunction;
* Patients who are suffering from other cancer;
* Other situations that the researchers considered unsuitable for this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No