Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

NCT ID: NCT03796364

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-07-31

Brief 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.

Detailed 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.

Conditions

Radiation Pneumonitis; Endostatin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

standard SRILI treatment

Group Type: ACTIVE_COMPARATOR

standard SRILI treatment

Intervention Type: 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.

observation group

Endostar® plus standard treatment

Group Type: EXPERIMENTAL

Endostar

Intervention Type: 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.

standard SRILI treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

standard SRILI treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Jianguo Sun

Deputy director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xinqiao Hospital of Chongqing

Chongqing, , China

Countries

China

Other Identifiers

XQonc-008

Identifier Type: -

Identifier Source: org_study_id