Radiation Therapy With Sorafenib for TACE-Resistant Hepatocellular Carcinoma (NCT01618253) | Clinical Trial Compass
WithdrawnPhase 1
Radiation Therapy With Sorafenib for TACE-Resistant Hepatocellular Carcinoma
Stopped: Closed due to poor accrual.
United States0Started 2012-06
Plain-language summary
To determine the maximum tolerated radiation dose with concurrent sorafenib for unresectable hepatocellular carcinoma that has not responded to transarterial chemoembolization.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 esopha…
What they're measuring
1
Maximum Tolerated Dose
Timeframe: From date of enrollment until 3 months after completion of treatment.