Clinical trial · Observational
Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY 43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY 43-9006)
Primary outcomes (2)
- measure
- Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.
- timeFrame
- up to 2 years
- measure
- Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.
- timeFrame
- up to 2 years
Secondary outcomes (4)
- measure
- Response before cytoreductive nephrectomy according to RECIST 1.1.
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Male and female patients ≥ 18 years old * Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment * Life expectancy of at least 16 weeks * Patients should have signed informed consent form Exclusion Criteria: * Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer. * All contra-indications according to the Russian marketing authorization: * Hypersensitivity to sorafenib or to any of the excipients. * Pregnancy and breast-feeding. * Age less than 18 years.
References
Publications (0)
Data not yet available