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

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.

Study Overview

• Status: Recruiting
• Conditions: Papillary Renal Cell Carcinoma
• Intervention / Treatment: Other: Observational, None intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: DingWei Ye, Postdoctoral; Phone Number: +86 18121299571; Email: USCC2012@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

unresectable locally advanced or metastatic papillary renal cell carcinoma

Description

Inclusion Criteria:

Patients must meet all the following criteria to be included in the real-world cohort:

1. Age ≥ 18 years at the index date
2. One of the following:

1)diagnosed with unresectable and locally advanced, or metastatic PRCC; 2)diagnosed with unresectable and locally advanced, or metastatic RCC, and with papillary (papillary ≥ 50%) as the dominant and presumed primary histology type.

3.Patients who received 1L therapy of sunitinib or sorafenib 4.Patients with tumor assessment or relevant clinical visit within 6-month follow-up since index date. (The rationale and details of 6-month minimal follow-up is presented in section 3.6). Death events within 6-month will be included.

Exclusion Criteria:

Patients who meet one or more following criteria will be excluded from the real-world cohort:

1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney;
2. Patients with history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years;

3. Patients who received systemic anti-cancer therapy for PRCC prior to the index date; The following is exception:

   Prior systemic anti-cancer therapy in the neoadjuvant or adjuvant setting are acceptable if it was completed more than 12 months before metastatic/recurrent disease was diagnosed.

   For patients who received prior systemic neoadjuvant/adjuvant therapies within 12 months before metastatic/recurrent disease was diagnosed, the neoadjuvant/adjuvant therapy will be counted as 1L therapy.

   Patients are deemed eligible if the first therapy was only sustained for ≤ 3 days.

4. Patients with missing both day and month of index date;
5. Patients with severe conditions that are greater or equal to grade 3 by the definition of CTCAE 5.0 criteria when included into the study;
6. Patients who treated with any combination of chemotherapy, targeted therapy, or immunotherapy with sunitinib or sorafenib as 1L therapy.

Other exclusion criteria revised according to study D5086C00001 (SAMETA) will also be applied, only if explicit evidence can be identified in the EMR data.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
unresectable locally advanced or metastatic papillary renal cell carcinoma	Other: Observational, None intervention; Observational, None intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective is to characterize the real-world PFS (rwPFS) with either sunitinib or sorafenib.	The rwPFS is defined as time from the initiation of first dose of sunitinib or sorafenib until investigator-reported disease progression (assessed by physician's notes or radiology report), or death due to any cause (in the absence of progression), whichever occurred first.	at least 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary objective is to characterize the rwPFS with sunitinib.	The rwPFS is defined as time from the initiation of first dose of sunitinib until investigator-reported disease progression (assessed by physician's notes or radiology report), or death due to any cause (in the absence of progression), whichever occurred first.	at least 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the OS with either sunitinib or sorafenib monotherapy	OS is defined as time from initiation of sunitinib or sorafenib until the date of death due to any cause.	at least 6 months
To characterize the real-world ORR (rwORR) with either sunitinib or sorafenib monotherapy	The measure of interest is rwORR, defined as the proportion of participants who have reached CR or PR as determined by investigator-reported assessment.	at least 6 months
To characterize the time-to-treatment discontinuation (TTD) with either sunitinib or sorafenib monotherapy	The TTD is defined as time from the date of initiation of sunitinib or sorafenib till their discontinuation due to any reasons or death.	at least 6 months
To characterize the OS with sunitinib monotherapy.	OS is defined as time from initiation of sunitinib until the date of death due to any cause.	at least 6 months
To characterize the rwORR with sunitinib monotherapy.	The measure of interest is rwORR, defined as the proportion of participants who have reached CR or PR as determined by investigator-reported assessment.	at least 6 months
To characterize the TTD with sunitinib monotherapy.	The TTD is defined as time from the date of initiation of sunitinib till its discontinuation due to any reasons or death.	at least 6 months
To characterize the rwPFS with sorafenib monotherapy.	The rwPFS is defined as time from the initiation of first dose of sorafenib until investigator-reported disease progression, or death due to any cause, whichever occurred first.	at least 6 months
To characterize the OS with sorafenib monotherapy.	OS is defined as time from initiation of sorafenib until the date of death due to any cause.	at least 6 months
To characterize the rwORR with sorafenib monotherapy.	The measure of interest is rwORR, defined as the proportion of participants who have reached CR or PR as determined by investigator-reported assessment.	at least 6 months
To characterize the TTD with sorafenib monotherapy.	The TTD is defined as time from the date of initiation of sorafenib till its discontinuation due to any reasons or death.	at least 6 months
To describe the adverse events (AEs) in Chinese patients of locally advanced or metastatic PRCC treated with either sunitinib or sorafenib monotherapy/ treated with sunitinib monotherapy/ treated with sorafenib monotherapy	AEs will be evaluated in terms of: Occurrence and frequency Seriousness AE with outcome of death AEs leading to discontinuation of sunitinib or sorafenib	at least 6 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: DingWei Ye, Postdoctoral, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: June 9, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: sunitinib;; papillary renal cell carcinoma;; sorafenib;; real world study.
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: D5086R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No