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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04984148
Other study ID # GDREC2019152H
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date January 31, 2024

Study information

Verified date November 2021
Source Guangdong Provincial People's Hospital
Contact Yi Pan
Phone +862083827812
Email panyiff011@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Consolidation immunotherapy of immune checkpoint inhibitor (ICI) following chemoradiotherapy (CRT) is the current standard of care for patients with unresectable locally advanced non-small cell lung cancer (NSCLC) as it improves both progression-free survival and overall survival. However, a substantial proportion of patients still experience disease recurrence despite consolidation ICI. It is important for personalized treatment to predict the efficacy of consolidation ICI. PD-L1 expression is used as a predictive biomarker for ICI response and efficacy in advanced NSCLC, but its role in patients with stage III disease is unclear. One important reason is PD-L1 testing performed on pre-CRT tissue may not reflect changes in PD-L1 expression after CRT. CT-based radiomics approaches have been successfully applied to generate imaging biomarkers as decision support tools for clinical practice. The hypothesis of this study is that CT radiomics model can assess PD-L1 status after CRT and predict the efficacy of CRT combined with ICI in unresectable locally advanced NSCLC.


Description:

This is an observational longitudinal prospective study. CT scan is performed before radiotherapy, during radiotherapy and at the end of radiotherapy in patients with unresectable locally advanced NSCLC who undergo CRT. Radiomic features were extracted from CT images and baseline PD-L1 expression is assessed. CT-based radiomics models is developed to assess PD-L1 expression and predict the efficacy of ICI.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date January 31, 2024
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histological or cytological proven non-small cell lung cancer - Unresectable stage III according to American Joint Committee of Cancer stage (the eighth edition) - 18 years or older Exclusion Criteria: - Previous thoracic radiotherapy - Palliative treatment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CT
Contrast-enhanced thoracic computed tomography

Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital Shenzhen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The association of CT radiomics features with PD-L1 expression of the tumor To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy 12 weeks
Secondary Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI To construct CT radiomics model for evaluating progression-free survival in patients undergo chemoradiotherapy followed by ICI From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, assessed up to 5 years
Secondary Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI to assess the association between CT radiomics features and overall survival From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years
Secondary Association between CT radiomics model and ICI related pneumonitis To develop CT radiomics signatures for predicting ICI related pneumonitis 5 years
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