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

November 6, 2021 updated by: YI PAN, Guangdong Provincial People's Hospital

Construction of CT Radiomics Model to Assess PD-L1 Status and Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with stage III NSCLC undergo radical intervention.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Diagnostic test: CT
Contrast-enhanced thoracic computed tomography
Other Names:
  • Radiomics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association of CT radiomics features with PD-L1 expression of the tumor
Time Frame: 12 weeks
To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI
Time Frame: 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
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
Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI
Time Frame: From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years
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
Association between CT radiomics model and ICI related pneumonitis
Time Frame: 5 years
To develop CT radiomics signatures for predicting ICI related pneumonitis
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Collaborators

Shenzhen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC2019152H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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