Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | standard SRILI treatment |
|
| observation group | Experimental | Endostar® plus standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Drug | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinqiao Hospital of Chongqing | Chongqing | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41014160 | Derived | Chen G, Zhu J, Jian C, Chen X, Niu K, Yang Q, Tang S, Qin S, Feng Y, Xie L, Zhuo W, Sun J. Efficacy and safety of Rh-endostatin in the treatment of radiation pneumonitis in non-small cell lung cancer. Oncologist. 2025 Nov 11;30(11):oyaf318. doi: 10.1093/oncolo/oyaf318. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017564 | Radiation Pneumonitis |
| D000087525 | Radiation Fibrosis Syndrome |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
Not provided
Not provided
| ID | Term |
|---|---|
| C522911 | endostar protein |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| standard SRILI treatment | Drug | 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. |
|
| 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 |
| D011832 |
| Radiation Injuries |
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |