Radiation PneumonitisPhase 2NCT03796364
Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis
A Phase 2 study testing Endostar and standard SRILI treatment in people with Radiation Pneumonitis and Endostatin, run by Xinqiao Hospital of Chongqing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Pneumonitis, Endostatin
- What is being tested?
- Endostar and standard SRILI treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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- The patient asked to be withdrawn from the trial;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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Endostar, standard SRILI treatment
- Keywords
- endostatin, Radiotherapy, Radiation pneumonitis, Radiation fibrosis
- Medical subject headings
- Radiation Pneumonitis, Radiation Fibrosis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
Also called standard SRILI treatment
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 treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | standard SRILI treatment Receives: Drug: standard SRILI treatment |
| observation group | Experimental | Endostar® plus standard treatment Receives: Drug: Endostar; Drug: standard SRILI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week12
Secondary outcomes (2)
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.
Measured: 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.
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Sep 2018
- Primary completion31 May 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796364
- Sponsor's protocol ID
- XQonc-008
- Status last verified
- Feb 2024
- First submitted
- 25 Dec 2018
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41014160
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis
- ClinicalTrials.gov ID
- NCT03796364
- Acronym / sponsor ID
- XQonc-008
- Conditions
- Radiation Pneumonitis, Endostatin
- Keywords
- endostatin, Radiotherapy, Radiation pneumonitis, Radiation fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: standard SRILI treatmentstandard SRILI treatment |
| observation group | Experimental | Drug: Endostar, Drug: standard SRILI treatmentEndostar® plus standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndostarAlso: standard SRILI treatmentPatients 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. | Drug | observation group |
| standard SRILI treatmentPatients 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 | control group, observation group |
Primary outcome
recrudescence rate of RP（Radiation pneumonitis）
Time frame: 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.
2 secondary outcomes
remission rate of RP
Time frame: at week 12
incidence rate of RF（Radioactive fibrosis）
Time frame: at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 41014160Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endostar and standard SRILI treatment in people with Radiation Pneumonitis and Endostatin, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recrudescence rate of RP（Radiation pneumonitis） (time frame: at week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.