CClinicalTrials.gg
Sign In
RecruitingNCT05219851Updated Mar 15, 2024

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

An observational study in Cancer Patients, sponsored by Hubei Cancer Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Hubei Cancer Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cancer Patients

Keywords

  • IMRT
  • Radiotherapy
  • Immune checkpoint inhibitor
  • Pneumonitis
  • Risk factors
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 250 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Hubei Cancer Hospital is the lead sponsor of 25 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients treated with the product will be enrolled in the investigation

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy
  2. Non-thoracic radiotherapy patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • RadiationCancer patients underwent thoracic intensity-modulated radiotherapy

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

06

What researchers measure

Primary outcomes

  1. Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.

    All 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.

    Time frame: 6 months after last-patient- radiation

07

Study locations

1 of 1 sites recruiting
  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
    • Guang Han, MD.Phd · Contact · 13886048178
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05219851
Lead sponsor
Hubei Cancer Hospital
Responsible party
HAN GUANG (Clinical Professor, Hubei Cancer Hospital) — Principal investigator
First posted
Feb 2, 2022
Start date
Jun 1, 2022
Primary completion
Mar 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Mar 15, 2024

Study contacts

Guang Han, MD.;Ph.D
Contact
hg7913@hotmail.com
13886048178

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pneumonia→

Other studies from this sponsor

Hubei Cancer Hospital

Start the discussion