Clinical trial · Observational
Correlation Between Sorafenib Plasma Concentrations, Toxicity and Disease Control Rate in Patients Treated by Sorafenib for Hepatocellular Carcinoma
NCT02834546CI-TRIAL-00044900ACTEScompletedClinicalTrials.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 aim of this pilot study is to correlate the sorafenib plasma concentration to observed toxicity and to the disease control rate in 100 patients undergoing a palliative treatment of hepatocellular carcinoma (HCC). If some correlations are observed, we will consider planning a larger interventional study to adjust sorafenib daily dose to plasma concentration.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib plasma concentration 4 weeks after treatment initiation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with HCC treated with sorafenib
- interventionNames
- Biological: Sorafenib plasma concentration 4 weeks after treatment initiation
Primary outcomes (1)
- measure
- Adverse events related to Sorafenib needing a dose adjustment or a symptomatic medication
- timeFrame
- Up 8 weeks after sorafenib treatment introduction
Secondary outcomes (4)
- measure
- Adverse events notification
- timeFrame
- Week 8, 16, month 6 and 12 after sorafenib treatment introduction
- measure
- Radiological response assessed by scan or MRI
- timeFrame
- Week 8, 16, month 6 and 12 after sorafenib treatment introduction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects \> 18 years age * Possibility of regular monitoring * Ability to understand and willingness to sign written informed consent. * Hepatocellular carcinoma histologically diagnosed or in case of inability to perform a histology by non-invasive radiological criteria endorsed by EASL/AASLD (a) presence of known cirrhosis and (b) identification of a focal hepatic lesion measuring at least 1cm in diameter with contrast uptake in the arterial phase and rapid wash out in the venous /late phase on two imaging techniques * Patient not eligible for curative treatment (transplantation, resection, destruction or percutaneous chemo-embolization) or HCC still evolving after failure of a specific treatment * ECOG ≤ 2 * Child-Pugh A or B * Score BCLC B or C Exclusion Criteria: * Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study * Cirrhosis CHILD C * Score BCLC D * ECOG \> 2 * Digestive bleeding within 30 days before inclusion * Subject has had a liver transplant or waiting for a liver transplant * Subject previously treated with sorafenib * Childbearing or breastfeeding women
References
Publications (0)
Data not yet available
No reference posted for this study.