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A Phase 1 Study of Sorafenib Integrated With Chemoembolization for Patients With Unresectable Hepatocellular Carcinoma

Phase 1
18 Years
Not Enrolling
Hepatocellular Carcinoma, Liver Cancer, Localized Unresectable Liver Cancer

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Trial Information

A Phase 1 Study of Sorafenib Integrated With Chemoembolization for Patients With Unresectable Hepatocellular Carcinoma


I. To evaluate the toxicity and safety of integrating sorafenib with chemoembolization for
unresectable hepatocellular carcinoma.


I. To observe the imaging response (AASLD/EASL modification of RECIST) and time to
progression following chemoembolization in conjunction with sorafenib.


Patients receive oral sorafenib tosylate twice daily. Beginning 2 weeks later, patients
undergo chemoembolization with cisplatin, doxorubicin hydrochloride, and mitomycin C.

Chemoembolizaton repeats once a month for up to 4 procedures in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3

Inclusion Criteria


- Histologically confirmed hepatocellular carcinoma

- AND/OR Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) consistent
with liver cirrhosis AND at least one solid liver lesion > 2cm with arterial-phase
enhancement and delayed washout regardless of alpha-feto protein levels (AFP)

- AND/OR AFP > 400ng/mL AND evidence of at least one solid liver lesion > 2cm
regardless of specific imaging characteristics on CT or MRI

- Patient is not a candidate for transplantation, resection, or ablation; for whom the
intended therapy is chemoembolization

- Patient meets clinical criteria for treatment with chemoembolization

- Absolute contraindications to chemoembolization include an uncorrectable bleeding
disorder, uncorrectable contrast sensitivity, leukopenia (white blood cell count <
1000/uL), cardiac or renal insufficiency (serum creatinine > 2.0mg/dL), hepatic
encephalopathy, jaundice, or dilated intrahepatic bile ducts

- Portal vein occlusion is a relative contraindication and chemoembolization can be
performed only if there are collateral vessels with hepato-pedal flow demonstrated

- Hepatic compromise as determined by the following combination of parameters is a
contraindication to therapy: lactate dehydrogenase > 425 U/L, aspartate
aminotransferase > 100 U/L, total bilirubin > 2.0 mg/dL and > 50% liver volume
replaced by tumor

- Patients may have been treated with ablation or resection in the past, but no sooner
than 4 weeks before study registration

- Patients may NOT have been previously treated with sorafenib, chemoembolization,
radioembolization, or systemic chemotherapy with cytotoxic agents or molecularly
targeted agents

- ECOG performance status =< 2

- Life expectancy of greater than 3 months

- Platelets >= 50,000/mcL

- Total bilirubin =< 2.0 mg/dl

- AST(SGOT)/ALT(SGPT) =< 3X institutional upper limit of normal

- Creatinine =< 1.5 mg/dl

- INR =< 1.5

- 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

- Because agents used in this trial are known to be teratogenic, women of child-bearing
potential and men must agree to use adequate contraception (hormonal or barrier
method of birth control; abstinence) prior to study entry and for the duration of
study participation

- Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately

- Ability to understand and the willingness to sign a written informed consent document


- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sorafenib

- History of radiologic contrast reactions not controlled by standard premedications

- Patients must not be taking cytochrome P450 enzyme inducing drugs

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that
would limit compliance with study requirements

- Pregnant women are excluded from this study

- Breastfeeding should be discontinued

- Prophylactic use of G-CSF or GM-CSF is not permitted on this trial

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose adjustment, number and percentage of subjects with adverse events, laboratory changes, number and percentage of subjects with laboratory values that are outside the pre-determined ranges, cumulative toxicity, and TLT.

Outcome Time Frame:

8 months

Safety Issue:


Principal Investigator

Michael Soulen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 08208



Start Date:

September 2009

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Localized Unresectable Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283