Clinical trial · Observational
Real World Evidence of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma
Retrospective, Multicenter, Real-world Observational Study of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma.
NCT07354282CI-TRIAL-00101300SOGUG-TIVOREALcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The SOGUG-TIVOREAL study is a retrospective observational study with medications. This study is based on the retrospective collection of data from patients who have been treated with Tivozanib as first-line therapy between 03/01/2019 and 08/31/2024 for metastatic renal cell carcinoma (mRCC).
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 |
|---|---|---|---|
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Day 1
- description
- To evaluate the progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of progression-free survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median time of survival from the start of treatment with Tivozanib until tumor progression or death from any cause, whichever occurs first. RECIST 1.1
Secondary outcomes (8)
- measure
- Overall survival (OS) in favorable risk group
- timeFrame
- Day 1
- description
- To evaluate the overall survival (OS) of patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of overall survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median survival time from the start of treatment with Tivozanib until death from any cause. RECIST 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. \- Patients ≥ 18 years old. 2. \- Who have signed the informed consent form, except for patients who were deceased at the time of inclusion. 3. \- Histological diagnosis of stage IV clear cell renal carcinoma. 4. \- Who started treatment with Tivozanib as first-line therapy between March 1, 2019, and August 31, 2024. 5. \- Who received treatment at the participating center. Exclusion Criteria: 1. \- Patients previously treated at another center who were later referred to one of the participating centers. In this case, the patient will be included in the center where the treatment was initiated. 2. \- Explicit objection by the subject or their legal representative to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.