Evaluation of Sorafenib in Combination With Local Micro-therapy Guided by Gd-EOB-DTPA Enhanced MRI in Patients With Inoperable Hepatocellular Carcinoma
Inclusion Criteria:
- Age: 18-85 years
- Diagnosis of hepatocellular carcinoma
- If primary diagnosis of HCC: diagnosis based on the following criteria:
- cyto-histological criteria, OR
- radiological criteria: Focal lesion >1 cm with arterial hypervascularization in
2 coincident imaging techniques (CT, MRI, or US), OR
- combined criteria: one imaging technique showing a focal lesion 1-2 cm with
arterial hypervascularization AND AFP levels >400 ng/mL, OR
- combined criteria: one imaging technique showing a focal lesion >2 cm with
arterial hypervascularization AND AFP levels >200 ng/mL
- If extrahepatic metastases: liver-dominant disease
- Stage BCLC A, B, or C
- Child-Pugh A, Child-Pugh B up to 7 points (in patients receiving anticoagulant
therapy: Child-Pugh score up to 5 points; INR category not regarded for calculation
of the Child-Pugh score)
- Willing to comply with all study procedures
- Has voluntarily given written informed consent
Exclusion Criteria:
- If female, pregnant or breast feeding (females of child-bearing potential must use
adequate contraception and must have a negative pregnancy test performed within 7
days prior to inclusion into this study)
- If male, not using adequate birth control measures
- One or more of the following:
- Hemoglobin <10g/dL,
- WBC <2,500 cells/mm3,
- ANC <1,500 cells/mm3,
- platelets <50,000/mm3,
- ECOG performance status >2
- Life expectancy <16 weeks
- Extrahepatic metastases (except metastases to bone, lymph nodes, and adrenal glands
which do not constitute an exclusion criterion)
- Patients with known GFR <30 mL/min/1.73m2
- PT-INR/PTT >1.5 times the upper limit of normal (patients on anticoagulation therapy
will be allowed to participate provided that no prior evidence exists of an
underlying abnormality in anticoagulation)
- uncontrolled infections at the time of microtherapy
- Child-Pugh score >7 points; in patients receiving anticoagulant therapy: Child-Pugh
score >5 points (INR category not regarded for calculation of the Child-Pugh score)
- Uncontrolled ascites
- tumor load of the whole liver >70%
- Contraindications for study medications according to product labeling or procedures
(sorafenib, Primovist®, x-ray contrast agents, SIR-Spheres®, RFA, MRI, CT) incl. any
contraindication to the trans-arterial interventional procedure (e.g., allergy
against x-ray contrast agents, uncontrolled hyperthyroidism)
- Prior resection of the papilla of Vater (e.g., Whipple procedure) or bile duct stent
across the papilla
- Significant cardiovascular disease; e.g., myocardial infarction within 6 months of
inclusion, chronic heart failure (New York Heart Association class III or IV),
unstable coronary artery disease
- Uncontrolled hypertension
- Thrombotic or embolic events including transient ischemic attacks within the past 6
months
- History of hemorrhage / bleeding events of grade 3 or worse
- Previous variceal bleeding within the past 3 months
- Previous malignancy other than carcinoma in situ of the skin or the cervix uteri
within 5 years prior to inclusion
- History of organ transplant (including prior liver transplantation)
- HIV, congenital immune defect, any immunosuppressive therapy for autoimmune disease
(rheumatoid arthritis) or inflammatory bowel disease
- Mental conditions rendering the subject incapable to understand the nature, scope,
and consequences of the trial
- Close affiliation with the investigational site; e.g. first-degree relative of the
investigator.
- Participating in another therapeutic clinical trial or has completed study
participation in another therapeutic clinical trial within 30 days of enrolment into
this trial
- Having been previously enrolled in this clinical trial