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
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- Withdrawn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.
Investigators
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