Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

Radiation Pneumonitis Clinical Trial

Official title:

Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796364
• Other study ID #: XQonc-008
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Endostatin
• Fibrosis
• Pneumonia
• Radiation Pneumonitis

Intervention

Drug:
• Endostar
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.
• standard SRILI treatment
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.

Locations

Country	Name	City	State
China	Xinqiao Hospital of Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

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