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

Shenzhen Hornetcorn Bio-technology Company, LTD60 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC

Interventions

gemcitabineDRUG

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

DC-CTLBIOLOGICAL

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

cisplatinumDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jingzhou Central hospital Immunotherapy center

Jingzhou, Hubei, China

Outcomes

Primary Outcomes

Progress-free survival

Time frame: 3 years

Secondary Outcomes

Overall survival

Time frame: 3 years

Central Contacts

Zi L Zhang, researcher

CONTACT

18107168013

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.