Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

Conditions
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Radiation Pneumonitis, Endostatin

Intervention / Treatment
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* Drug: Endostar
* Drug: standard SRILI treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>standard SRILI treatment | Drug: standard SRILI treatment<br>* Patients in the control group were treated with current routine radiation pneumonia. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.<br>|
| Experimental: observation group<br>Endostar® plus standard treatment | Drug: Endostar<br>* Patients in the observation group were treated with routine radiation pneumonia and Endostar. Endostar usage: continuous intravenous pumping of Endostar(14 doses each time) over 5 days. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.<br>* Other names: standard SRILI treatment;Drug: standard SRILI treatment<br>* Patients in the control group were treated with current routine radiation pneumonia. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recrudescence rate of RP（Radiation pneumonitis） | 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. | at week12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate of RP | Patients in the observation group were treated with routine radiation pneumonia and Endostar. Results are expressed as a percentage. Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for remission rate of RP at week 12. | at week 12 | 
| incidence rate of RF（Radioactive fibrosis） | 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 incidence rate of RF at week 12. | at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endostatin, Radiotherapy, Radiation pneumonitis, Radiation fibrosis