Skip to main content
Clinical Trials/NCT01533727
NCT01533727
Withdrawn
Phase 2

A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer

Sun Yat-sen University1 site in 1 countryAugust 2011

Overview

Phase
Phase 2
Intervention
Autologous CIK Transfusion plus Chemotherapy
Conditions
Non-small Cell Lung Cancer
Sponsor
Sun Yat-sen University
Locations
1
Primary Endpoint
the relapse rate
Status
Withdrawn
Last Updated
12 years ago

Overview

Brief Summary

Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
December 2020
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Li Zhang

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.
  • with an Eastern CooperativeOncology Group performance status of 0 or 1,
  • at least 18 years of age
  • adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula
  • patients had fully recovered from its acute effects.

Exclusion Criteria

  • HIV positive
  • autoimmune disease
  • immune deficiency disorder
  • organ transplantation
  • received high dose glucocorticoid or other immune depressant within 4 weeks
  • active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
  • life threatening medical condition

Arms & Interventions

Group A

Autologous CIK Transfusion plus Chemotherapy

Intervention: Autologous CIK Transfusion plus Chemotherapy

Group B

chemotherapy alone

Intervention: chemotherapy alone

Outcomes

Primary Outcomes

the relapse rate

Time Frame: 30 months

Study Sites (1)

Loading locations...

Similar Trials