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Evaluation of Sorafenib in Combination With Local Micro-therapy Guided by Gd-EOB-DTPA Enhanced MRI in Patients With Inoperable Hepatocellular Carcinoma


Phase 2
18 Years
85 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

time to recurrence

Outcome Description:

In patients in whom local ablation therapy is appropriate, to determine if the sorafenib in combination with radiofrequency ablation (RFA) prolongs the time-to-recurrence (TTR) in comparison with RFA + placebo.

Outcome Time Frame:

13-18 months (average time to recurrence)

Safety Issue:

Yes

Principal Investigator

Jens Ricke, Prof. Dr.

Investigator Role:

Study Director

Investigator Affiliation:

University of Magdeburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

RAD85

NCT ID:

NCT01126645

Start Date:

December 2010

Completion Date:

September 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular

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