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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT01004978

Run by

National Cancer Institute (NCI)

People needed

235

Starts

2009-10-28

Expected to finish

2022-12-21

Last updated by the study team

2024-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
• Histologically confirmed
• Magnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)
• AFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI
• Patients must have hepatocellular carcinoma (HCC) limited to the liver; there must be no clinical or radiographic evidence of extrahepatic HCC
• Portal lymphadenopathy IS permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy
• Staging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration
• Patients must have measurable disease constituting < 50% of liver parenchyma within 4 weeks of registration
• Patients may not have ascites detectable on physical examination
• Patients must not be candidates for curative resection, orthotopic liver transplantation, or radiofrequency ablation (RFA)
• Patients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration
• Patients may have undergone previously attempted curative liver resection
• Patients may NOT have been previously treated with brachytherapy such as yttrium-90 microsphere
• Patients may NOT have been previously treated with sorafenib, chemoembolization, or systemic chemotherapy including cytotoxic agents or molecularly targeted agents
• Branch portal vein invasion by tumor is permitted but patients with main portal vein invasion by tumor are not eligible
• Patients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration
• Serum total bilirubin =< 2.0 mg/dL
• Alkaline phosphatase < 5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN
• Serum creatinine =< 1.5 mg/dL
• Platelet count >= 50,000/mm\^3
• Patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
• Patients must have no clinical signs of heart failure and meet New York Heart Association functional classification I or II defined as:
• Class I - patients with no limitation of activities; they suffer no symptoms from ordinary activities
• Class II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion

Where it is running

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• John L McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Marin Cancer Care Inc — Greenbrae, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Veterans Affairs Medical Center -Washington DC — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Lakeland Regional Health Hollis Cancer Center — Lakeland, Florida, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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