Radiation Pneumonitis Clinical Trial
Official title:
Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis
Verified date | February 2024 |
Source | Xinqiao Hospital of Chongqing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | July 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients defined as NSCLC who could not be operated on, phase III-IV; 2. EOCG PS: 0-3; 3. The clinical diagnosis is RILI, with grade 2-3; 4. No major organ dysfunction, such as heart failure and chronic obstructive pneumonia; 5. No Endostar use contraindication; 6. Volunteer to participate, good compliance, can cooperate with the test observation, and sign a written informed consent. Exclusion Criteria: 1. Patient compliance is poor and violates the test regulations; 2. Major organ dysfunction like liver and kidney occurs, such as myocardial infarction, angina pectoris, liver transaminase increased significantly; 3. Hemorrhage or thrombus occurs, anticoagulant medication is required; 4. Serious adverse drug reactions occur during treatment; 5. The patient asked to be withdrawn from the trial; 6. Other antiangiogenic drugs were used. |
Country | Name | City | State |
---|---|---|---|
China | Xinqiao Hospital of Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Xinqiao Hospital of Chongqing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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