Clinical trial · Interventional
Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma
A Multicenter National Phase II Open Study Coupled With Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Hepatocellular Carcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of inclusion
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with advanced/inoperable fibrolamellar hepatocellular carcinoma. Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrolamellar Hepatocellular Carcinoma | Fibrolamellar Carcinoma | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sutent | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patient treated
- description
- patient who receive sunitinib
- interventionNames
- Drug: Sutent
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- 1 year
- description
- to evaluate the objective response according to RECIST Criteria 1.1
Secondary outcomes (5)
- measure
- Objective response
- timeFrame
- 1 year
- description
- to evaluate objective response to sunitinib according to secondary radiological criteria (evaluation on CT scan of: tumor density, % of tumor necrosis and tumor vascularisation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Fibrolamellar hepatocellular carcinoma histopathologically proven * Inoperable/advanced (Tumor recurrence inoperable or metastatic with no surgical indication). * Available Tumor tissue for analysis(biopsy or surgical specimen) * Performance status WHO ≤ 2. * Adequate organ function : * Hematology (absolute neutrophil count equal or superior to 1,5 x 10\*9/l , platelet equal or superior to 100 x 10\*9/l), * clearance of creatinine \> 60 ml/min), * AST/ALT ≤ 5 N, PAL ≤ 5 N, total bilirubin ≤ 2N. Exclusion Criteria: * Hypersensitivity to sunitinib. * Contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants. * Any severe acute or chronic co-morbid that may compromise to comply with study participation : uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list) * Known brain metastases. * Diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri * Current treatment on another clinical trial. * Prior treatment with an investigational agent within 4 weeks * Patient on i.v bisphosphonate therapy
References
Publications (0)
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