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

Pulmonary Fibrosis Clinical Trial

Official title:

Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01917877
• Other study ID #: QCH-20030801
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2013
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2023
• Source: Qingdao Central Hospital
• Contact: youxin ji, md
• Phone: 86532-68665078
• Email: ji6677[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Exclusion Criteria:

• chronic pulmonary fibrosis and infection-induced pulmonary fibrosis

• active bleeding

• uncontrolled high blood pressure

• unstable systemic disease

• prior exposure to VEGF inhibitor

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• 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
• Dexamethasone
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

Locations

Country	Name	City	State
China	Qingdao Central Hospital	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary function		up to 8 weeks
Secondary	thoracic CT scan		up to 8 weeks