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

Phase 2

• Conditions: NSCLC
• Interventions: Drug: gemcitabine; Drug: cisplatinum; Biological: DC-CTL

• Registration Number: NCT02766348
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

Brief Summary

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

Detailed 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).

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-06
• Last Update Submitted: 2016-05-06
• Study First Posted: 2016-05-09
• Last Update Posted: 2016-05-09
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	cisplatinum	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
DC-CTL	DC-CTL	After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment
DC-CTL	cisplatinum	After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment
Chemotherapy	gemcitabine	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
DC-CTL	gemcitabine	After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment

Primary Outcome Measures

Name	Time	Method
Progress-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years

Trial Locations

Locations (1)

Jingzhou Central hospital Immunotherapy center; 🇨🇳 Jingzhou, Hubei, China