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

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer; Lung Cancer

Treatments: Drug: Cisplatin; Biological: D-CIK; Drug: Gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02651441

HYK-NSCLC

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

D-CIK

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Biological: D-CIK

Drug: Cisplatin

Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Cisplatin