Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

Phase 2

Completed

• Conditions: Radiation Pneumonitis; Endostatin
• Interventions: Drug: standard SRILI treatment; Drug: Endostar

• Registration Number: NCT03796364
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-08
• Primary Completion: 2020-05-31
• Study Completion: 2020-07-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	standard SRILI treatment	standard SRILI treatment
observation group	standard SRILI treatment	Endostar® plus standard treatment
observation group	Endostar	Endostar® plus standard treatment

Primary Outcome Measures

Name	Time	Method
recrudescence rate of RP（Radiation pneumonitis）	at week12	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.

Secondary Outcome Measures

Name	Time	Method
incidence rate of RF（Radioactive fibrosis）	at week 12	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.
remission rate of RP	at week 12	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.

Trial Locations

Locations (1)

Xinqiao Hospital of Chongqing; 🇨🇳 Chongqing, China