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

S

Shenzhen Hornetcorn Biotechnology

Status and phase

Unknown
Phase 2

Conditions

NSCLC

Treatments

Drug: gemcitabine
Biological: DC-CTL
Drug: cisplatinum

Study type

Interventional

Funder types

Industry

Identifiers

NCT02766348
HYK-DC-CTL-NSCLC

Details and patient eligibility

About

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

Full description

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).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

DC-CTL
Experimental group
Description:
After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment
Treatment:
Drug: cisplatinum
Biological: DC-CTL
Drug: gemcitabine
Chemotherapy
Active Comparator group
Description:
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
Treatment:
Drug: cisplatinum
Drug: gemcitabine

Trial contacts and locations

1

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Central trial contact

Zi L Zhang, researcher

Data sourced from clinicaltrials.gov

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