Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

NCT03796364 | Completed Phase 2

• 1 other identifier: XQonc-008
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Pneumonitis; Endostatin

Keywords

endostatin; Radiotherapy; Radiation pneumonitis; Radiation fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• remission rate of RP

  at week 12

• incidence rate of RF（Radioactive fibrosis）

  at week 12

Study Arms (2)

control group

ACTIVE COMPARATOR

standard SRILI treatment

Drug: standard SRILI treatment

observation group

EXPERIMENTAL

Endostar® plus standard treatment

Drug: Endostar; Drug: standard SRILI treatment

Interventions

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.

Also known as: standard SRILI treatment

observation group

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.

control group; observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients defined as NSCLC who could not be operated on, phase III-IV;
• EOCG PS: 0-3;
• The clinical diagnosis is RILI, with grade 2-3;
• No major organ dysfunction, such as heart failure and chronic obstructive pneumonia;
• No Endostar use contraindication;
• Volunteer to participate, good compliance, can cooperate with the test observation, and sign a written informed consent.

You may not qualify if:

• Patient compliance is poor and violates the test regulations;
• Major organ dysfunction like liver and kidney occurs, such as myocardial infarction, angina pectoris, liver transaminase increased significantly;
• Hemorrhage or thrombus occurs, anticoagulant medication is required;
• Serious adverse drug reactions occur during treatment;
• The patient asked to be withdrawn from the trial;
• Other antiangiogenic drugs were used.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

Xinqiao Hospital of Chongqing

Chongqing, 400000, China

Location

Related Publications (1)

• 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.

  PMID: 41014160 DERIVED

MeSH Terms

Conditions

Radiation Pneumonitis; Radiation Fibrosis Syndrome

Interventions

endostar protein

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: January 8, 2019
• Study Start: September 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)