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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01004978
• Date of registration: 29/10/2009
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 400
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01004978
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: John S. Kauh

• Name: John Kauh
• Affiliation: Eastern Cooperative Oncology Group

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of hepatocellular carcinoma (HCC) according to 1 of the following criteria:

- Histologically confirmed disease

- Liver cirrhosis AND = 1 solid liver lesion > 2 cm with early enhancement and
delayed enhancement washout on CT scan or MRI regardless of alpha-fetoprotein
levels (AFP)

- AFP > 400 ng/mL AND = 1 solid liver lesion > 2 cm regardless of specific imaging
characteristics on CT scan or MRI

- Disease must be limited to the liver

- No clinical or radiographic evidence of extra hepatic HCC

- Portal vein lymphadenopathy is allowed for patients with hepatitis B or C

- Branch portal vein invasion by tumor allowed

- No main portal vein invasion by tumor

- Measurable disease constituting < 50% of liver parenchyma within the past 4 weeks

- Child Pugh score of A or B7 within the past 4 weeks

- No ascites detectable on physical evaluation

- Not a candidate for curative resection, orthotopic liver transplantation, or
radiofrequency ablation (RFA)

- ECOG performance status 0-1

- Life expectancy = 3 months

- Platelet count = 50,000/µL

- Total bilirubin = 2.0 mg/dL

- Alkaline phosphatase < 5 times upper limit of normal (ULN)

- AST and ALT < 5 times ULN

- Serum creatinine = 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to swallow pills

- No clinical signs of heart failure

- No NYHA class III or IV heart disease

- No evidence of bleeding diathesis or active gastrointestinal bleeding

- No known HIV positivity

- No other concurrent uncontrolled illness (except hepatitis B or C) including, but not
limited to, any of the following:

- Uncontrolled hypertension (i.e., optimally treated baseline BP > 150/90 mm Hg)

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness and/or addictive disorder that would limit compliance with
study requirements

- No allergy to iodine or gadolinium contrast that cannot be safely controlled with
premedication

- No prior brachytherapy (e.g., yttrium-90 microspheres)

- No prior sorafenib tosylate, chemoembolization, or systemic chemotherapy, including
cytotoxic agents or molecularly targeted agents

- Prior attempted curative liver resection allowed

- More than 4 weeks since prior RFA

- No concurrent cytochrome P450 enzyme-inducing drugs

- No concurrent prophylactic G-CSF or GM-CSF



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Adult Primary Hepatocellular Carcinoma

Localized Unresectable Adult Primary Liver Cancer

Recurrent Adult Primary Liver Cancer

Intervention(s)

Drug: cisplatin

Drug: doxorubicin hydrochloride

Drug: doxorubicin-eluting beads

Drug: mitomycin C

Drug: sorafenib tosylate

Other: placebo

Primary Outcome(s)

Progression-free survival [Time Frame: Time from randomization to progression or death without evidence of progression, assessed up to 4 years]

Secondary Outcome(s)

Incidence of adverse events, graded according to NCI CTCAE version 4.0 [Time Frame: Up to 4 years]

Overall survival [Time Frame: Time from randomization to death from any cause, or last known date of survival, assessed up to 4 years]

Secondary ID(s)

CDR0000657952

E1208

ECOG-E1208

NCI-2011-01981

U10CA021115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors