Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- recrudescence rate of RP（Radiation pneumonitis）
研究概览
简要总结
To verify the efficacy and safety of endostatin in the treatment of SRILI（symptomatic radiation-induced lung injury） and fibrosis. The results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.
详细描述
Radiotherapy is an important treatment of lung cancer, symptomatic radiation-induced lung injury (SRILR) is the most common complications. In view of the important role of endostatin in inhibiting angiogenesis and pro-inflammatory factors, Combined with randomized controlled clinical study and small sample clinical exploration, the investigators concluded that endostatin is a new clinical technique for the treatment of radiation pneumonia（RP） and radiation fibrosis（RF）, which can reduce the recurrence rate of RP. In order to verify the efficacy and safety of endostatin in the treatment of SRILI and fibrosis, the investigators intend to use a prospective, randomized, multicenter clinical trial to classify unresectable phase III-IV Non-small cell lung cancer（NSCLC） patients with SRILI above grade 2 into the control group (standard SRILI treatment) and observation group (Endostar® plus standard treatment) on a 1:1 randomized basis. The results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.
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
- •Patients defined as NSCLC who could not be operated on, phase III-IV;
- •EOCG PS: 0-3;
- •The clinical diagnosis is RILI, with grade 2-3;
- •No major organ dysfunction, such as heart failure and chronic obstructive pneumonia;
- •No Endostar use contraindication;
- •Volunteer to participate, good compliance, can cooperate with the test observation, and sign a written informed consent.
排除标准
- •Patient compliance is poor and violates the test regulations;
- •Major organ dysfunction like liver and kidney occurs, such as myocardial infarction, angina pectoris, liver transaminase increased significantly;
- •Hemorrhage or thrombus occurs, anticoagulant medication is required;
- •Serious adverse drug reactions occur during treatment;
- •The patient asked to be withdrawn from the trial;
- •Other antiangiogenic drugs were used.
研究组 & 干预措施
control group
standard SRILI treatment
干预措施: standard SRILI treatment (Drug)
observation group
Endostar® plus standard treatment
干预措施: Endostar (Drug)
observation group
Endostar® plus standard treatment
干预措施: standard SRILI treatment (Drug)
结局指标
主要结局
recrudescence rate of RP（Radiation pneumonitis）
时间窗: at week12
Patients in the observation group were treated with routine radiation pneumonia and Endostar. Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for recrudescence rate of RP at week 12. The calculation method is: number of relapse cases / total number of treatment groups × 100%; RP is classified according to CTCAE4.0, patients with grade 2 or higher are improved after treatment, and those who are assessed to be grade 2 or higher are considered recrudescence). Results are expressed as a percentage.
次要结局
- incidence rate of RF（Radioactive fibrosis）(at week 12)
- remission rate of RP(at week 12)
研究者
Jianguo Sun
Deputy director
Xinqiao Hospital of Chongqing