An exploratory study of sorafenib for patients listed for transplantation due to HCC

Phase 1

• Conditions: Patients >18 years with hepatocellular carcinoma, on waiting list for liver transplantation; MedDRA version: 12.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrent; MedDRA version: 12.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectable

• Registration Number: EUCTR2010-024306-36-SE
• Lead Sponsor: Västra Götalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-30
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 21

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 < 1,5 ULN

ECOG <2

No acute infections at time of therapy initiation

Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified