Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-31

Brief Summary

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Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.

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Detailed Description

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60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL 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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NSCLC

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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DC-CTL

After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

gemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks

DC-CTL

Intervention Type BIOLOGICAL

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

cisplatinum

Intervention Type DRUG

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

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 day 1 an day 8, repeat every 3 weeks

cisplatinum

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 day 1 an day 8, repeat every 3 weeks

Intervention Type DRUG

DC-CTL

8×10\^9 DC-CTL 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

cisplatinum

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

Intervention Type DRUG

Other Intervention Names

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Gemzar

Eligibility Criteria

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Inclusion Criteria

* The patient who have signed the informed consent;
* Histologically confirmed with NSCLC at stage III-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; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(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