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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- the relapse rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group A
Autologous CIK Transfusion plus Chemotherapy
干预措施: Autologous CIK Transfusion plus Chemotherapy (Drug)
Group B
chemotherapy alone
干预措施: chemotherapy alone (Drug)
结局指标
主要结局
the relapse rate
时间窗: 30 months
次要结局
未报告次要终点
研究者
Li Zhang
Professor
Sun Yat-sen University