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

Recruiting

• Conditions: Cancer Patients

• Registration Number: NCT05219851
• Lead Sponsor: Hubei Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-02
• Study Start: 2022-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-03-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.	6 months after last-patient- radiation	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.

Trial Locations

Locations (1)

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China