Patients >18 years with hepatocellular carcinoma, on waiting list for liver transplantation MedDRA version: 12.1 Level: LLT Classification code 10019829 Term: Hepatocellular carcinoma recurrent MedDRA version: 12.1 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable
Conditions
Interventions
Trade Name: Nexavar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SORAFENIB TOSILATE
CAS Number: 475207-59-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Västra Götalandsregionen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with HCC without prior medical anti-tumour therapy, basically eligible for LTx at screening. Tumour size according to the UCSF criteria are allowed. HCC diagnosed by histology or according to non-invasive European Association for the study of the liver (EASL) criteria (only cirrhotic patients): 1. radiological criteria: two coinciding imaging techniques: Focal lesion >2 cm with arterial hypervascularization in a cirrhotic liver 2. Combined criteria: one imaging technique associated with alpha-fetoprotein (AFP): Focal lesion > 2 cm with arterial hypervascularization + AFP levels> 400 ng/ml Pretreatment CT or MRI without evidence of radiographically definable vascular invation or extrahepatic disease, not older that 6 weeks Sufficient hematologic, liver and renal function PT-INR/PTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Child-Pugh socre more than 7p at time of inclusion Expected waiting time for transplantation below three months Residual radiological definiable extrahepatic disease, portal vein involvement or lymph node involvement on CT, MRI or bone scan. Patients who are not potentially eligible for LTx are excluded Patients with prior or concomitant systemic anticancer therapy Patients with significant cardiovascular disease such as myocardial infarction, chronic heart failure or unstable coronary artery disease Patints with severe pulmonary disease that would be hazardous for LTx Uncontrolled hypertension, defined as systolic blood pressure >150 mg Hg or diastolic pressure >90 mm Hg, dispite optimal management Thrombotic or embolic events including transient ischemic attacks within the pas 6 months Patients with previous malignancy, within 5 years prior treatment, other then carcinoma in situ of the skin and the cervix. Previous HCC, treated locally with ablation or resection is permitted Patients <18 years Pregnant or breast-feeding patients. Both men and women must use adequate barrier birth control measures. Patients with uncontrolled infections or HIV sero-positive patients History or hypersensitivity to the investigational medicinal product Mental conditions rendering hte patient incapable to understand the nature, scope and consequences of the study No patient will be allowed to enroll in this study more than once Prior organ transplantation Concomitant immunosuppressive treatment Participation in other pharmaceutical clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of neoadjuvant therapy with Nexavar, measured by changes of the CT perfusion blood flow from baseline to 12 weeks follow-up ;Secondary Objective: To evaluate Diminishing amount of circulating tumour cells Changes in other CT perfusion parameters (blood volume, mean transit time, permeability surface area) Tumour response to sorafenib treatment according to modified RECIST criteria and to histopathology of explanted livers Percentage of patients reaching transplantation, thus avoiding dropout from waiting list Percentage of patients with radiographic tumour progression according to modified RECIST, while on waitinglist Impact of sorafenib on quality of life, assessed by EORTC QLQ C-30 and HCC-18 Impact of sorafenib treatment on liver function and toxicity while on waiting list. CTC v4.0 will used Postoperative 30-day morbidity and mortality after liver transplantation. Surgicla morbidity will be classified according to Clavien in a five grade scale.;Primary end point(s): Change in CTp variable blood flow from baseline to 12 weeks follow-up. | — |
Countries
Sweden
Outcome results
None listed