Pretreatment 18F-FDG PET/CT Radiomics for Predicting Response to First-Line Targeted Therapy Plus Immunotherapy in Metastatic Renal Cell Carcinoma

NCT07827482 | Completed

• 1 other identifier: MRCTA, ECFAH of FMU[2026]810
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center retrospective observational study evaluates whether quantitative imaging features from pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) can help predict response to first-line tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) therapy in patients with metastatic renal cell carcinoma. The study reviews existing medical records and imaging data from 228 patients treated at the First Affiliated Hospital of Fujian Medical University between January 2019 and December 2025. Treatment was selected as part of routine clinical care and was not assigned by the study. Imaging features are extracted separately from the primary kidney tumor and metastatic lesions and are then combined to develop a patient-level multi-lesion radiomics model. Treatment response is assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 approximately 12 weeks after treatment initiation. Complete response or partial response is classified as response, whereas stable disease or progressive disease is classified as non-response. The study compares imaging-based, clinical, and combined prediction models and also evaluates their association with progression-free survival.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

18F-FDG PET/CT; Radiomics; Multi-lesion Radiomics; Tyrosine Kinase Inhibitor; Immune Checkpoint Inhibitor; Treatment Response; Progression-Free Survival; Axitinib; Pembrolizumab; Toripalimab

Outcome Measures

Primary Outcomes (1)

• Treatment Response According to RECIST Version 1.1

  Number and percentage of participants categorized as having complete response, partial response, stable disease, or progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status.

  At 12 weeks after initiation of first-line TKI plus ICI therapy

Secondary Outcomes (1)

• Progression-Free Survival

  From treatment initiation to radiologically confirmed disease progression, death, or last follow-up, assessed up to 24 months

Other Outcomes (1)

• Predictive Performance of the Multi-Lesion Radiomics Model

  At 12 weeks after initiation of first-line TKI plus ICI therapy

Study Arms (1)

Metastatic Renal Cell Carcinoma Cohort

Patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus either pembrolizumab or toripalimab as part of routine clinical care. Clinical, pathological, imaging, treatment response, and follow-up data were retrospectively collected. Treatment was not assigned by the study.

Diagnostic Test: Pretreatment 18F-FDG PET/CT; Drug: Axitinib Plus Pembrolizumab or Toripalimab

Interventions

Pretreatment 18F-FDG PET/CT DIAGNOSTIC_TEST

Pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography was performed before initiation of first-line systemic therapy. Primary renal tumors and eligible metastatic lesions were evaluated for conventional metabolic parameters and radiomic features.

Metastatic Renal Cell Carcinoma Cohort

Axitinib Plus Pembrolizumab or Toripalimab DRUG

Patients received first-line axitinib 5 mg orally twice daily combined with either pembrolizumab 200 mg intravenously every 3 weeks or toripalimab 240 mg intravenously every 3 weeks as part of routine clinical care. Treatment was not assigned by the observational study.

Metastatic Renal Cell Carcinoma Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus pembrolizumab or toripalimab at the First Affiliated Hospital of Fujian Medical University. Eligible patients were identified retrospectively from institutional medical and imaging records. The study included patients with adequate clinical, pathological, imaging, treatment response, and follow-up data.

You may qualify if:

• Pathologically confirmed metastatic renal cell carcinoma.
• Pretreatment 18F-FDG PET/CT performed before initiation of first-line systemic therapy.
• Receipt of first-line tyrosine kinase inhibitor plus immune checkpoint inhibitor combination therapy.
• At least one measurable lesion according to RECIST version 1.1.
• Available clinicopathological, imaging, treatment response, and follow-up data.

You may not qualify if:

• Receipt of systemic anticancer therapy before the pretreatment 18F-FDG PET/CT examination.
• An interval of more than 1 month between pretreatment PET/CT and initiation of first-line systemic therapy.
• Unavailable treatment response assessment or follow-up data.
• Incomplete key clinicopathological or imaging information.
• PET/CT image quality inadequate for lesion segmentation or radiomics analysis.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib; pembrolizumab; toripalimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Chief Physician

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 18, 2026
• Study Start: June 1, 2019
• Primary Completion: April 10, 2026
• Study Completion: June 30, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)