Clinical trial · Observational
Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma
NCT03289273CI-TRIAL-00067121completedClinicalTrials.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)
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
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 |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- uHCC patients treated with regorafenib
- description
- Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (1)
- measure
- Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
- timeFrame
- Up to 24 months
- description
- The primary endpoint is the safety of regorafenib in patients with uHCC, defined as the frequency of documented TEAEs, including serious adverse events (SAEs). Safety will be assessed in all patients who receive at least one dose of regorafenib regardless of prior treatment.
Secondary outcomes (5)
- measure
- Overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed diagnosis of unresectable HCC * Physician-initiated decision to treat with regorafenib (prior to study enrollment) Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice * Past treatment with regorafenib
References
Publications (0)
Data not yet available
No reference posted for this study.