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COMPLETED
NCT07827482

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

Sponsor: First Affiliated Hospital of Fujian Medical University

View on ClinicalTrials.gov

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.

Official title: Application of 18F-FDG PET/CT in Evaluating Treatment Response to Targeted Therapy Plus Immunotherapy in Patients With Metastatic Renal Cell Carcinoma: A Single-Center Retrospective Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

228

Start Date

2019-06-01

Completion Date

2026-06-30

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Pretreatment 18F-FDG PET/CT

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.

DRUG

Axitinib Plus Pembrolizumab or Toripalimab

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.

Locations (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China