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

S

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)

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

Trial contacts and locations

1

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Central trial contact

Guang P Wang, Physician

Data sourced from clinicaltrials.gov

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