Clinical trial NCT03796364: Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis
Official title: Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiation Pneumonitis
Endostatin
Keywords: endostatin
Radiotherapy
Radiation pneumonitis
Radiation fibrosis
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: recrudescence rate of RP（Radiation pneumonitis）
timeFrame: at week12
Secondary outcomes:
measure: remission rate of RP
timeFrame: at week 12
measure: incidence rate of RF（Radioactive fibrosis）
timeFrame: at week 12
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
Study officials:
References: