Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Radiation Pneumonitis; Endostatin
• Intervention / Treatment: Drug: standard SRILI treatment; Drug: Endostar

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400000
    • Xinqiao Hospital of Chongqing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; standard SRILI treatment	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.
Experimental: observation group; Endostar® plus standard treatment	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.; 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.; Other Names: standard SRILI treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Radiation pneumonitis; endostatin; Radiation fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Fibrosis; Pneumonia; Radiation Pneumonitis; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein
• Other Study ID Numbers: XQonc-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No