NCT02651441

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 24, 2016

Status Verified

January 1, 2016

Enrollment Period

3.2 years

First QC Date

January 5, 2016

Last Update Submit

May 23, 2016

Conditions

Lung CancerNon-small Cell Lung Cancer

Keywords

D-CIKlung cancer

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival

    3 years

Secondary Outcomes (4)

  • Overall survival

    3 years

  • Quality of life (QOL)

    3 years

  • Phenotypic analysis of T cells

    1 year

  • Severity of adverse events

    1 year

Study Arms (2)

D-CIK

EXPERIMENTAL

After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.

Drug: GemcitabineDrug: CisplatinBiological: D-CIK

Chemotherapy

ACTIVE COMPARATOR

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

Drug: GemcitabineDrug: Cisplatin

Interventions

GemcitabineDRUG

Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.

Also known as: Gemzar
ChemotherapyD-CIK
CisplatinDRUG

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

Also known as: cisplatinum
ChemotherapyD-CIK
D-CIKBIOLOGICAL

8×10\^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

D-CIK

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient who have singed the informed consent;
  • Histologically confirmed with NSCLC at stage Ⅲb～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; ALT, AST, BUN and 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510010, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

GemcitabineCisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Zhi Z Zhang, Professor

    Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang P Wang, Physician

CONTACT

+86 13810661960WangGP@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 11, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2019

Study Completion

August 1, 2019

Last Updated

May 24, 2016

Record last verified: 2016-01

Locations

CN(1)