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

Not Recruiting

Trial ID: NCT01004978


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.

Official Title

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

Stanford Investigator(s)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD

Professor of Radiology (Interventional Radiology)

Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD

Moghadam Family Professor

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)


Inclusion Criteria:

   - 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

   - 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

   - 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

   - 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

   - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
   0 or 1

   - Patients must have a life expectancy of at least 3 months

   - Patients must not be known to be human immunodeficiency virus (HIV) positive

   - Patients must not have other uncontrolled intercurrent illnesses excluding HBV or HCV,
   including, but not limited to: uncontrolled hypertension, symptomatic congestive heart
   failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive
   disorders that would limit compliance with study requirements

      - Uncontrolled hypertension is defined as optimally treated baseline blood pressure
      that exceeds 150/90 mm Hg

   - Patients must not be taking cytochrome P450 enzyme inducing drugs

   - Age >= 18 years

   - Women must not be pregnant or breast-feeding; all females of childbearing potential
   must have a blood test or urine study within 2 weeks prior to registration to rule out

   - Women of childbearing potential and sexually active males must be strongly advised to
   use an accepted and effective method of contraception

   - Patients must not have an allergy to iodine or gadolinium contrast that cannot be
   safely controlled with premedication

   - Patient must be able to swallow pills, as study medications cannot be crushed


drug: cisplatin

drug: Mitomycin

other: Placebo Administration

procedure: Computed Tomography

drug: Doxorubicin Hydrochloride

drug: Doxorubicin-Eluting Beads

other: Laboratory Biomarker Analysis

procedure: Magnetic Resonance Imaging

other: Pharmacological Study

drug: Sorafenib Tosylate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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