CompletedPhase 2

Sorafenib and Micro-therapy Guided by Primovist Enhanced MRI in Patients With Inoperable Liver Cancer

Germany529 participantsStarted 2010-12

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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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

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)

What they're measuring

time to recurrence

Timeframe: 13-18 months (average time to recurrence)

overall survival

Timeframe: 10-15 months (average survival)

Primovist®-enhanced MRI is non-inferior or superior compared with contrast-enhanced multislice CT

Timeframe: 3 years

Trial details

NCT IDNCT01126645

SponsorUniversity of Magdeburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-25

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