Sunitinib or sorafenib for unresectable or metastatic papillary kidney cancer in China

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 project uses medical records to see how well sunitinib or sorafenib works as first-line treatment for Chinese adults with unresectable or metastatic papillary kidney cancer.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: sunitinib, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07024680 on ClinicalTrials.gov

What this trial studies

This is a multi-center, retrospective observational study using electronic medical record data from Grade-A tertiary hospitals in China to characterize effectiveness and safety of first-line sunitinib or sorafenib in adults with unresectable locally advanced or metastatic papillary renal cell carcinoma. Patient-level data including labs, radiology and pathology reports, physician notes, prescriptions, procedures, diagnoses, and outcomes will be extracted and entered into an electronic data capture system. The target population includes patients who started sunitinib or sorafenib between September 1, 2007 and mid-2024, with at least six months of follow-up or death within six months recorded. The study is non-interventional and analyzes real-world treatment patterns and outcomes across participating hospitals.

Who should consider this trial

Good fit: Adults (age ≥18) in China with unresectable locally advanced or metastatic papillary RCC who received first-line sunitinib or sorafenib and have at least six months of follow-up data (or a recorded death within six months).

Not a fit: Patients with non-papillary kidney cancers (for example papillary urothelial carcinoma or renal pelvis cancer), those who received prior systemic therapy in the metastatic setting, or those without accessible hospital records are unlikely to be included or to benefit from this analysis.

Why it matters

Potential benefit: If successful, this analysis could help identify which drug provides better real-world outcomes and safety for Chinese patients with advanced papillary RCC, informing treatment choices.

How similar studies have performed: Both sunitinib and sorafenib have shown activity in kidney cancers and some small or registry studies suggest benefit in papillary RCC, but high-quality randomized evidence specific to the papillary subtype is limited.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: DingWei Ye, Postdoctoral — Fudan University
• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Papillary Renal Cell Carcinoma; papillary renal cell carcinoma; sunitinib; sorafenib; real world study.