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

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ClinicalTrials.gov Identifier: NCT04984148
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
Shenzhen University
Information provided by (Responsible Party):
YI PAN, Guangdong Provincial People's Hospital

Brief 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.

Condition or disease Intervention/treatment
Stage III Non-small Cell Lung Cancer Diagnostic Test: CT

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


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 Name: Radiomics




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Association between CT radiomics model and ICI related pneumonitis [ Time Frame: 5 years ]
    To develop CT radiomics signatures for predicting ICI related pneumonitis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with stage III NSCLC undergo radical intervention.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984148


Contacts
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Contact: Yi Pan +862083827812 panyiff011@163.com

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yi Pan, Dr.    +86-020-83827812    panyiff01@163.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Shenzhen University
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Responsible Party: YI PAN, Head of the Department of Radiation Oncology, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04984148    
Other Study ID Numbers: GDREC2019152H
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YI PAN, Guangdong Provincial People's Hospital:
non-small cell lung cancer
radiomics
immunotherapy
chemoradiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms