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Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study)

Phase 2
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study)

Inclusion Criteria:

Patients with advanced/inoperable HCC not eligible for radical or loco-regional therapies
Male or female patients ≥ 18 years of age Life expectancy of at least 12 weeks at
screening Histologically or cytologically documented HCC

At least one tumor lesion that meets both of the following criteria:

1. The lesion is measurable as per RECIST criteria, and

2. The lesion has not been subject to previous loco-regional therapy (such as radiation
therapy, TACE, TAE, PEI, RFA, or cryoablation) Patients previously treated with
loco-regional treatments are eligible provided that previously treated lesions are
not selected as target lesions. Local therapy must be completed at least 4 weeks
prior to the baseline scan ECOG PS of 0, 1, or 2 Cirrhotic status of Child-Pugh class
A or B Barcelona-Clinic Liver Cancer (BCLC) stage B or C

The following laboratory parameters:

- Platelet count ≥ 60 x 109 /L

- Haemoglobin ≥ 8,5 g/dL

- Total bilirubin ≤ 3 mg/dL

- Alanine transaminase (ALT) and Aspartato transaminase (AST) ≤ 5 x upper limit of

- Amylase and lipase < 1,5 x the upper limit of normal

- Serum creatinine ≤ 1,5 x the upper limit of normal

- Prothrombin time (PT)-international normalized ratio (INR) < 2,3 or PT < 0,6 seconds
above control. Patients who are being therapeutically anticoagulated with an agent
such as Coumadin or heparin will be allowed to participate provided that no prior
evidence of underlying abnormality in these parameters exists.

Written informed consent prior to any study specific screening procedures with the
understanding that the patient has the right to withdraw from the study at any time,
without prejudice.

Exclusion Criteria:

- Previous or concurrent cancer that is distinct in primary site or histology from HCC,
except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
tumors (Ta, Tis & T1).

- Any cancer curatively treated > 3 years prior to entry is permitted Renal failure
requiring hemo- or peritoneal dialysis

- History of cardiac disease: congestive heart failure > New York Heart Association
(NYHA) class 2;

- active coronary artery disease (CAD);

- cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
ordigoxin), or uncontrolled hypertension.

- Myocardial infarction more than 6 months prior to study entry is permitted if there
is no evidence of active CAD

- Active clinically serious infections (> Grade 2 [NCI CTCAE] )

- Known history of human immunodeficiency virus (HIV) infection

- Known Central Nervous System tumors including metastatic brain disease

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry

- History of organ allograft

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

- Patients unable to swallow oral medications

- Any condition that is unstable or which could jeopardize the safety of the patient
and his/her compliance in the study

- Pregnant or breast-feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within seven days prior to the start of study drug.

- Both men and women enrolled in this trial must use adequate barrier birth control
measures during the course of the trial

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas


Italy: Ministry of Health

Study ID:




Start Date:

April 2007

Completion Date:

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular