Real World Study of Effectiveness of Sunitinib or Sorafenib to Chinese Unresectable Locally Advan… (NCT07024680) | Clinical Trial Compass
RecruitingNot Applicable
Real World Study of Effectiveness of Sunitinib or Sorafenib to Chinese Unresectable Locally Advanced or Metastatic PRCC
China150 participantsStarted 2025-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years at the index date
✓. One of the following:
✓.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 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:
✕. 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;
What they're measuring
1
The primary objective is to characterize the real-world PFS (rwPFS) with either sunitinib or sorafenib.