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

NCT02766348 | Unknown Phase 2

• 1 other identifier: HYK-DC-CTL-NSCLC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NSCLC

Keywords

DC-CTL, NSCLC

Outcome Measures

Primary Outcomes (1)

• Progress-free survival

  3 years

Secondary Outcomes (1)

• Overall survival

  3 years

Study Arms (2)

DC-CTL

EXPERIMENTAL

After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment

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

Chemotherapy

ACTIVE COMPARATOR

After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.

Drug: gemcitabine; Drug: cisplatinum

Interventions

gemcitabine DRUG

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

Also known as: Gemzar

Chemotherapy; DC-CTL

DC-CTL BIOLOGICAL

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

DC-CTL

cisplatinum DRUG

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

Chemotherapy; DC-CTL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Hornetcorn Bio-technology Company, LTD: lead

Study Sites (1)

Jingzhou Central hospital Immunotherapy center

Jingzhou, Hubei, 434020, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Zi L Zhang, researcher

  Jingzhou Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Zi L Zhang, researcher

CONTACT

18107168013

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)