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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the relapse rate

Outcome Time Frame:

30 months

Safety Issue:

No

Principal Investigator

Li Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

2010014

NCT ID:

NCT01533727

Start Date:

August 2011

Completion Date:

December 2020

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Cytokine-Induced Killer Cell
  • NSCLC
  • adjuvant therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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