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The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors

The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors.in Real-world Clinical Practice: a Multicenter, Prospective, Open, Non-interventional Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05219851
Enrollment
250
Registered
2022-02-02
Start date
2022-06-01
Completion date
2025-10-31
Last updated
2024-03-15

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

Conditions

Cancer Patients

Keywords

IMRT, Radiotherapy, Immune checkpoint inhibitor, Pneumonitis, Risk factors

Brief summary

The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.

Detailed description

1. Incidence of acute radiation pneumonitis (aRPs) in in patients with prior receipt of immune checkpoint inhibitors. 2. Risk factors (especially analysis of the dosimetric risk factor) which may affect the product of aRPs events. 3. Establish a model to predict aRPs and guide clinical treatment.

Interventions

RADIATIONCancer patients underwent thoracic intensity-modulated radiotherapy

Cancer patients underwent thoracic intensity-modulated radiotherapy, previously received ICIs

Sponsors

Hubei Cancer Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Pathologically or cytologically confirmed malignant tumor 2. Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy

Exclusion criteria

1. Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy 2. Non-thoracic radiotherapy patients

Design outcomes

Primary

MeasureTime frameDescription
Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.6 months after last-patient- radiationAll suspected diagnoses of pneumonitis (regardless of grade) were centrally reviewed by a multidisciplinary committee consisting of at least one radiologist, pulmonologist, and oncologist. CT (or PET-CT) imaging was reviewed for each patient, which was then compared to the radiation treatment plan; other causes such as infection or tumor progression had to be ruled out using the appropriate workup.

Countries

China

Contacts

Primary ContactGuang Han, MD.;Ph.D
hg7913@hotmail.com13886048178

Outcome results

None listed

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