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

NCT01917877 | Unknown Phase 2 DMC

• 1 other identifier: QCH-20030801
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis

Keywords

Becacizumab; pulmonary fibrosis; irradiation; chemotherapy

Outcome Measures

Primary Outcomes (1)

• pulmonary function

  up to 8 weeks

Secondary Outcomes (1)

• thoracic CT scan

  up to 8 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

Drug: Bevacizumab

control

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Bevacizumab DRUG

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

Also known as: Avastin (Genentech/Roche)

study group

Dexamethasone DRUG

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

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

You may not qualify if:

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

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Bevacizumab; Dexamethasone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• youxin ji, md

  Qingdao Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

youxin ji, md

CONTACT

86532-68665078; ji6677@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 7, 2013
• Study Start: August 1, 2013
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-02

Locations

CN (1)