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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01917877
Enrollment
30
Registered
2013-08-07
Start date
2013-08-01
Completion date
2025-12-30
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

Keywords

Becacizumab, pulmonary fibrosis, irradiation, chemotherapy

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.

Interventions

DRUGDexamethasone

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

DRUGBevacizumab

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

Sponsors

Qingdao Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
pulmonary functionup to 8 weeks

Secondary

MeasureTime frame
thoracic CT scanup to 8 weeks

Countries

China

Contacts

Primary Contactyouxin ji, md
ji6677@gmail.com86532-68665078

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026