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

March 27, 2023 updated by: Qingdao Central Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital
        • Contact:
          • youxin ji, md
          • Phone Number: 86-532-68665078
        • Principal Investigator:
          • youxin ji, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
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
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
Other Names:
  • Avastin (Genentech/Roche)
Active Comparator: control
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Drug: Dexamethasone
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pulmonary function
Time Frame: up to 8 weeks
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
thoracic CT scan
Time Frame: up to 8 weeks
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Anticipated)

December 30, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QCH-20030801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Fibrosis

Clinical Trials on Bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe