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

NCT07024680 | Recruiting

• 1 other identifier: D5086R00001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Papillary Renal Cell Carcinoma

Keywords

papillary renal cell carcinoma;; sunitinib;; sorafenib;; real world study.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary objective is to characterize the rwPFS with sunitinib.

  at least 6 months

Other Outcomes (11)

• To characterize the OS with either sunitinib or sorafenib monotherapy

  at least 6 months

• To characterize the real-world ORR (rwORR) with either sunitinib or sorafenib monotherapy

  at least 6 months

• To characterize the time-to-treatment discontinuation (TTD) with either sunitinib or sorafenib monotherapy

  at least 6 months

Study Arms (1)

unresectable locally advanced or metastatic papillary renal cell carcinoma

unresectable locally advanced or metastatic papillary renal cell carcinoma

Other: Observational, None intervention

Interventions

Observational, None intervention OTHER

Observational, None intervention

unresectable locally advanced or metastatic papillary renal cell carcinoma

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

unresectable locally advanced or metastatic papillary renal cell carcinoma

You may qualify if:

• Patients must meet all the following criteria to be included in the real-world cohort:
• Age ≥ 18 years at the index date
• One of the following:
• )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.
• 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.

You may not qualify if:

• Patients who meet one or more following criteria will be excluded from the real-world cohort:
• Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney;
• Patients with history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years;
• 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.
• Patients with missing both day and month of index date;
• 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;
• Patients who treated with any combination of chemotherapy, targeted therapy, or immunotherapy with sunitinib or sorafenib as 1L therapy.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

Study Officials

• DingWei Ye, Postdoctoral

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: June 17, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)