Hepatocellular Carcinoma Clinical Trial
Official title:
Evaluation of Sorafenib in Combination With Local Micro-therapy Guided by Gd-EOB-DTPA Enhanced MRI in Patients With Inoperable Hepatocellular Carcinoma
The purpose of this study is to evaluate Sorafenib and local microtherapy guided by Primovist
enhanced MRI in patients with inoperable liver cancer (HCC).
Methodology:
Patients with a diagnosis of hepatocellular carcinoma will receive either:
- local ablation therapy of liver lesions by radiofrequency ablation followed by sorafenib
or placebo (local ablation group), or
- radioembolization (SIRT) + sorafenib or sorafenib alone (palliative treatment group).
In each study group, patients will be randomized to one of the two treatment arms following a
pre-defined randomization plan. Randomization will be on a 1:1 basis in the local ablation
group and on the basis of 10 (sorafenib only) : 11 (SIRT + sorafenib) in the palliative
treatment group.
Patients in the local ablation group will be followed at 2 months intervals for recurrence
and overall survival, patients in the palliative treatment group will be followed for overall
survival. Follow-up in each study group will end 24 months after inclusion of the last
patient into the respective study group.
The assignment of patients to the local ablation or palliative study group will be based on
the ablative potential of RFA (local ablation if ≤4 tumors, each ≤5 cm in size). Diagnostic
imaging will be used to guide this decision. The assignment to the local ablation or the
palliative treatment group will be made by the local investigator.
As a sub-study, all patients will undergo Primovist®-enhanced MRI in addition to
contrast-enhanced CT before assignment to one treatment group. The goal of the sub-study is
to assess the value of Primovist®-enhanced MRI to correctly stratify patients for a local
ablation or palliative treatment strategy. Primovist®-enhanced MRI will be compared with
contrast-enhanced multislice CT using a truth panel assessment as the standard of reference.
In addition, Primovist-enhanced MRI and contrast-enhanced CT will be obtained during
follow-up of patients in the local ablation group to assess its potential for detection of
recurrence.
n/a
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