At a glance
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A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion
In Brief
A Phase 3 clinical trial evaluating Cisplatin, Computed Tomography, and 8 other interventions for Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma. Completed, enrolled 235 participants across 281 sites.
Detailed Summary
This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Kinase inhibitors, such as sorafenib tosylate may stop the growth of tumor cells by blocking the action of an abnormal protein that signals cancer cells to multiply. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.
Study Details
Timeline
Interventions
Undergo TACE
Undergo CT scan
Undergo TACE
Undergo TACE
Correlative studies
Undergo MRI
Undergo TACE
Correlative studies
Given PO
Given PO