ISRCTN24081794
Completed
Phase 3
A prospective, randomised, double-blind, multicentre, phase III clinical study on transarterial chemoembolisation (TACE) combined with sorafenib versus TACE plus placebo in patients with hepatocellular cancer (HCC) before liver transplantation (LTx) -Heidelberg Liver Cancer Study (HeiLivCa Study)
niversity of Heidelberg (Germany)0 sites204 target enrollmentMay 30, 2008
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Heidelberg (Germany)
- Enrollment
- 204
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both male and female patients
- •2\. Patients with HCC without extrahepatic disease
- •3\. Patients with HCC without prior systemic therapy, basically eligible for liver transplantation (LTx) at screening
- •4\. HCC diagnosed by histology or per non\-invasive European Association for the Study of the Liver (EASL) criteria (only cirrhotic patients):
- •4\.1\. Radiological criteria: two coincident imaging techniques: focal lesion greater than 2 cm with arterial hypervascularisation
- •4\.2\. Combined criteria: one imaging technique associated with alpha\-fetoprotein (AFP): focal lesion greater than 2 cm with arterial hypervascularisation and AFP levels greater than 400 ng/ml
- •5\. Pretreatment computed tomography (CT) or magnetic resonance imaging (MRI) and bone scan without evidence of radiographically definable vascular invasion or extrahepatic disease not older than 28 days
- •6\. Sufficient haematologic, liver and renal function: Hb greater than 9\.0 g/%, white blood cell (WBC) count greater than 3,000 cells/mm^3 (absolute neutrophil count \[ANC] greater than 1\.500 cells/mm^3\), platelets greater than 75,000 cells/mm^3, bilirubin less than 3 mg/dl. Patients should have bilateral renal function, as determined by abdominal CT with serum creatinine less than 1\.5 mg/dl and creatinine clearance (CrCL) greater than 30 ml/min in 24 h urine or Modification of Diet in Renal Disease Rate (MDRD).
- •7\. Prothrombin time International Normalised Ratio (PT\-INR)/activated partial thromboplastin time (PTT) less than 1\.5 x upper limit of normal (patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
- •8\. Performance status: Karnofsky index greater than 70%
Exclusion Criteria
- •1\. Residual radiological definable extrahepatic disease, portal vein involvement or lymph node involvement in CT, MRI or bone scan. Patients who are not potentially eligible for LTx are excluded
- •2\. Patients with prior or concomitant systemic anticancer therapy or local tumour therapy (i.e. laser\-induced interstitial thermotherapy \[LITT]; percutaneous ethanol injection \[PEI], cryotherapy, radiofrequency ablation \[RFA]), or with prior TACE or with concomitant biologic\-response modifiers, strong CYP3A4 inhibitors
- •3\. Patients with significant cardiovascular disease such as myocardial infarction \<6 months previously, chronic heart failure (revised New York Hearth Association \[NYHA] grade III\-IV) or unstable coronary artery disease
- •4\. Patients with severe pulmonary disease that would be hazardous for LTx
- •5\. Uncontrolled hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg, despite optimal management
- •6\. Thrombotic or embolic events including transient ischaemic attacks within the past 6 months
- •7\. Haemorrhage/bleeding event greater than or equal to Grade 3 within 4 weeks of first dose of study drug
- •8\. Patients with contraindication to arterial procedure during TACE (portal or liver vein infiltration, allergy against contrast dye, uncontrolled hyperthyroidism)
- •9\. Patients with previous malignancy other than carcinoma in situ of the skin and the cervix within 5 years prior treatment
- •10\. Patients less than 18 years
Outcomes
Primary Outcomes
Not specified
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