drugset / Trial / NCT01004978

Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

NCT01004978

Phase 3 Completed 235 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-10-28
Primary completion
2021-02-11
Completion
2022-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule Oral
Background Cisplatin Other / unclassified
Background Doxorubicin Other / unclassified
Background Mitomycin C Other / unclassified