Radiation Therapy With Sorafenib for TACE-Resistant Hepatocellular Carcinoma

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.