Can you clarify the last statement ? Thanks ...we believe since the HEAT trial is not dealing with untreated patients.
Per exclusion criteria posted on Clinical Gov website for HEAT trial,
Exclusion Criteria:
•Have serious medical illnesses including, but not limited to, congestive heart failure, myocardial infarction or cerebral vascular accident within the last six months, or life threatening cardiac arrhythmias.
•Is scheduled for liver transplantation.
•Have previously received any treatment for HCC (except for study subjects being considered for completion of treatment or re-treatment).
•Have previously received any doxorubicin (study subjects being considered for completion of treatment or re-treatment may have received ThermoDox previously).
•Have extrahepatic metastasis.
•Are pregnant or breast-feeding. In women of childbearing potential, a negative pregnancy test (serum) is required prior to study treatment.
•Women of childbearing potential who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has undergone a vasectomy must use a second form of birth control).
•Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents to be used in this study.
•Have portal or hepatic vein tumor invasion/thrombosis.
•Have INR > 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for medical conditions unrelated to HCC such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld.
•Have platelet count < 75,000/mm3, absolute neutrophil count < 1500/mm3, or Hgb < 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA procedure).
•Have serum creatinine = 2.5 mg/dL or calculated creatinine clearance (CrCl) = 25.0 mL/min.
•Have serum bilirubin > 3.0 mg/dL.
•Have serum albumin < 2.8 g/dL.
•Have body temperature >1010F (38.30C) immediately prior to study treatment.
•Have contraindications to receiving doxorubicin HCl.
•Are being treated with other investigational agents.
•Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication (study subjects being considered for completion of treatment or re-treatment may have received ThermoDox previously).
•Have other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.
•Documented HIV positive.
•NYHA class III or IV functional classification for heart failure.
•Evidence of hemachromatosis.
•Have history of contrast-induced nephropathy.
AI
