CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

This study has been withdrawn prior to enrollment.
(Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.)
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01533727
First received: February 12, 2012
Last updated: December 5, 2013
Last verified: February 2012

February 12, 2012
December 5, 2013
August 2011
December 2017   (final data collection date for primary outcome measure)
the relapse rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01533727 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Autologous CIK Transfusion plus Chemotherapy
    vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w
  • Drug: chemotherapy alone
    vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;
  • Experimental: Group A
    Autologous CIK Transfusion plus Chemotherapy
    Intervention: Drug: Autologous CIK Transfusion plus Chemotherapy
  • Active Comparator: Group B
    chemotherapy alone
    Intervention: Drug: chemotherapy alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2020
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. HIV positive
  2. autoimmune disease
  3. immune deficiency disorder
  4. organ transplantation
  5. received high dose glucocorticoid or other immune depressant within 4 weeks
  6. active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  7. life threatening medical condition
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01533727
2010014
Yes
Li Zhang, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Li Zhang, MD Sun Yat-sen University
Sun Yat-sen University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP