Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab

Phase 2

Recruiting

• Conditions: Pulmonary Fibrosis
• Interventions: Drug: Dexamethasone; Drug: Bevacizumab

• Registration Number: NCT01917877
• Lead Sponsor: Qingdao Central Hospital

Brief Summary

Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not only compromise cancer treatment, but also influence patient's life qualities and even death. there are no specific treatment modalities for this treatment-induced complication. Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by Dexamethasone （10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone. The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30 cases.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

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Exclusion Criteria

• chronic pulmonary fibrosis and infection-induced pulmonary fibrosis
• active bleeding
• uncontrolled high blood pressure
• unstable systemic disease
• prior exposure to VEGF inhibitor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Dexamethasone	Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
study group	Bevacizumab	Bevacizumab 7mg/kg iv on day1 and 21, followed by Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

Primary Outcome Measures

Name	Time	Method
pulmonary function	up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
thoracic CT scan	up to 8 weeks

Trial Locations

Locations (1)

Qingdao Central Hospital; 🇨🇳 Qingdao, Shandong, China