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Real World Study of Effectiveness of Sunitinib or Sorafenib as First Line Therapy to Chinese Unresectable Locally Advanced or Metastatic Papillary Renal Cell Carcinoma: a Multi-center, Retrospective, Observational Study
This is a multi-center, observational, retrospective study designed to characterize the effectiveness and safety of sunitinib or sorafenib monotherapy in the treatment of Chinese adult patients with unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anticancer therapy in the metastatic setting. Electronic medical record (EMR) data of patients with 1L sunitinib or sorafenib monotherapy will be screened from Grade-A Tertiary hospitals in China. The study period is from 1st September 2007 to 31st December 2024.
This is a multi-center, observational, retrospective study designed to characterize the effectiveness and safety of sunitinib or sorafenib monotherapy in the treatment of Chinese adult patients with unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anticancer therapy in the metastatic setting. Data will be screened and collected from Grade-A Tertiary hospitals in different provinces across China. Relevant patient-level information will be screened from EMR in multiple information systems in these hospitals. Information on baseline covariates, exposures and outcomes will be collected from hospital, including laboratory results, radiology and pathology reports, physician and nurse notes, prescriptions written and dispensed, surgical procedures, primary and subsequent diagnoses, and other details of a patient's outpatient visits and hospital admissions. Patients' information data will be collected and entered into the electronic data capture (EDC) system. The study population consist of unresectable and locally advanced or metastatic PRCC patients in China who received 1L sunitinib or sorafenib between 1st September 2007 and 30th June 2024. Patients who were initially diagnosed with early stage PRCC and whose disease later progressed to unresectable and locally advanced or metastatic PRCC are eligible to be included in the study. Moreover, patients who relapsed after nephrectomy are also eligible to be included in the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Start Date
March 31, 2025
Primary Completion Date
July 14, 2026
Completion Date
July 14, 2026
Last Updated
November 18, 2025
150
ESTIMATED participants
Observational, None intervention
OTHER
AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479information.center@astrazeneca.comLead Sponsor
AstraZeneca
NCT05665361
NCT05122546
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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