Radiation Therapy With Sorafenib for TACE-Resistant Hepatocellular Carcinoma

Withdrawn before enrolling · Phase 1

Conditions studied: Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatoma, Liver Cancer

In brief

To determine the maximum tolerated radiation dose with concurrent sorafenib for unresectable hepatocellular carcinoma that has not responded to transarterial chemoembolization.

Key facts

Study ID

NCT01618253

Run by

Medical College of Wisconsin

People needed

0

Starts

2012-06-01

Expected to finish

2016-06-01

Last updated by the study team

2013-09-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiographic or histologic diagnosis of hepatocellular carcinoma (HCC).
• Maximum of 3 HCC lesions within the liver.
• No evidence of lymphadenopathy or metastatic disease per either CT or PET.
• Prior transarterial chemo-embolization (TACE) at least 28 days prior to initiation of protocol therapy.
• Evidence of either progressive disease or stable disease following TACE.
• Child Pugh Class A (score 5-6) or B (score 7).
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 (or Karnofsky ≥70%).
• Normal organ and marrow function (platelets >60,000/mc; hemoglobin ≥8.5 g/dL; international normalized ratio (INR) ≤2.3; albumin ≥2.8 g/dL; total bilirubin ≤3 mg/dL; aspartate aminotransferase (AST) / alanine aminotransferase (ALT) <5x upper limit of normal; creatinine ≤1.5x upper limit of normal).
• Negative human immunodeficiency virus serology.
• Negative pregnancy test for women of child bearing age.
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if…

• Less than 800 cc of normal liver.
• Child Pugh Class B (score 8-9) or C (score 10-15).
• Acute/active hepatitis B infection.
• Prior systemic chemotherapy or abdominal radiation therapy.
• Portal venous (main, primary right, or primary left trunks) or inferior vena cava thrombosis.
• Prior malignancy within 5 years of enrollment except for non-melanoma skin cancer.
• Prior history of myocardial infarction, cerebrovascular accident, or esophageal variceal bleed in the last 6 months.
• Pre-existing heart failure with either a clinical classification of New York Heart Association Class III or IV or cardiac ejection fraction of <45%.
• Systolic blood pressure > 160 mmHg or diastolic pressure > 100 mmHg despite optimal medical management.
• Pulmonary hemorrhage or other serious bleeding event (grade 2+) within 4 weeks initiation of protocol therapy.
• Prior history of scleroderma or active systemic lupus erythematosus.

Where it is running

• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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