Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel and Cisplatin in Advanced Non Small Cell Lung Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 14
- 主要终点
- Overall survival time of patients, quality of life
研究概览
简要总结
The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.
详细描述
Non-small cell lung cancer (NSCLC) accounts for 75% of all lung cancers. majority of patients of NSCLC patients are stage IIIA or IIIB patients are suitable for radiotherapy, which could not improve the survival rates of 5-10%. This study proposed Mycobacterium w (heat killed) in combination chemotherapy of Cisplatin and Paclitaxel along with radiotherapy for adjuvant therapy management of NSCLC in controlled clinical trial, which may prove the efficacy, better survival rate and quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document.
- •Histologically or cytologically confirmed Non-Small Cell Cancer, Stage IIIB or IV.
- •Age should be 18 years or above.
- •ECOG should be in 0-1 range.
- •Absolute neutrophil count ≥ 1,00,000/mm3
- •hemoglobin ≥ 9.0g/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)range of institution (5times ULN if liver metastasis present).
- •bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement).
- •Creatinine ≤ upper limit of normal (ULN) range of institution.
- •Negative pregnancy test for women of child bearing potential prior to entry into the trial.
排除标准
- •Patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
- •Patient with systematic brain metastasis.
- •History of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
- •Pregnant women or nursing women.
- •Uncontrolled intercurrent illness that would limit compliance with study requirements.
- •HIV positive patients.
- •Previous splenectomy.
研究组 & 干预措施
Chemotherapy
Paclitaxel + Cisplatin
干预措施: Paclitaxel & Cisplatin (Drug)
Chemoimmunotherapy
Paclitaxel + Cisplatin + Mycobacterium w
干预措施: Mycobacterium w. (Biological)
结局指标
主要结局
Overall survival time of patients, quality of life
时间窗: 12 months
次要结局
- Response rate, Hematological toxicity(12 months)