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

Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219851
• Other study ID #: HBCH-RT-2022-RP
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2024
• Source: Hubei Cancer Hospital
• Contact: Guang Han, MD.;Ph.D
• Phone: 13886048178
• Email: hg7913[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Patients
• Pneumonia
• Radiation Pneumonitis

Intervention

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

Locations

Country	Name	City	State
China	Hubei Cancer Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after last-patient- radiation