Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

Army Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Endostatin; Radiation Pneumonitis

Treatments: Drug: standard SRILI treatment; Drug: Endostar

Study type: Interventional

Funder types: Other

Identifiers

NCT03796364

XQonc-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

control group

Active Comparator group

Description:

standard SRILI treatment

Treatment:

Drug: standard SRILI treatment

observation group

Experimental group

Description:

Endostar® plus standard treatment

Treatment:

Drug: standard SRILI treatment

Drug: Endostar