NCT07024680

Real World Study of Effectiveness of Sunitinib or Sorafenib to Chinese Unresectable Locally Advanced or Metastatic PRCC

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Papillary Renal Cell Carcinoma

Interventions

Type	Name	Description
OTHER	Observational, None intervention	Observational, None intervention

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-07-14
• Completion: 2026-07-14
• First posted: 2025-06-17
• Last updated: 2025-11-18

Locations

1 site across 1 country: China