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

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 2

Conditions: NSCLC

Treatments: Biological: DC-CTL; Drug: cisplatinum; Drug: gemcitabine

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)

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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:

Biological: DC-CTL

Drug: cisplatinum

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