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Construction of CT Radiomics Model for Predicting the Efficacy of Immunotherapy in Patients With Stage III NSCLC

NCT ID: NCT04984148

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stage III Non-small Cell Lung Cancer

Keywords

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non-small cell lung cancer radiomics immunotherapy chemoradiotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trial cohort：Chemoradiotherapy followed by immunotherapy

Contrast-enhanced thoracic CT: before, during and after radiotherapy

Radiomics

PD-L1 testing (Histological analysis of biopsy)

Molecular Markers (Histological analysis of biopsy)

CT

Intervention Type DIAGNOSTIC_TEST

Contrast-enhanced thoracic computed tomography

Interventions

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CT

Contrast-enhanced thoracic computed tomography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Radiomics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen University

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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YI PAN

Head of the Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Pan

Role: CONTACT

Phone: +862083827812

Email: [email protected]

Facility Contacts

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Yi Pan, Dr.

Role: primary

Other Identifiers

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GDREC2019152H

Identifier Type: -

Identifier Source: org_study_id