A Multicenter, Prospective Real World Study on Recombinant Human Endostatin (Endostar) Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III Non-small-cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- PFS
研究概览
简要总结
The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.
详细描述
The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
- •at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
- •18-75 years of age;
- •Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
- •FEV1>1.0 L;
- •suitable function of bone marrow, liver, kidney and coagulation
排除标准
- •history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.
结局指标
主要结局
PFS
时间窗: 15 months
progress free survival
次要结局
- OS(3 years)
- DMFS(2 years)
- AEs(3 years)
- LRFS(2 years)