A Safety and Efficacy Study of DENSPM in Patients With Liver Cancer Who Are Not Eligible for Surgical Care

Exclusion Criteria

• •Has received localized therapy (e.g., radiotherapy, RFA, injection therapy, or chemoembolization)within 6 weeks prior to treatment, Day1. Prior local lesion-specific radiotherapy is acceptable only if the treated lesion(s) is/are not the only source of measurable disease or there is documented progression of the treated lesion(s) following completion of the therapy.
• •Has received any other systemic therapy for HCC within 3 weeks prior to treatment, Day 1. Prior therapy is acceptable only if there is documented progression following completion of the therapy.
• •Has received another investigational therapy within 30 days prior to study entry
• •Has any unstable serious or life-threatening medical condition, other than HCC (e.g., unstable angina, other cancer diagnosis with the exception of basal cell carcinoma, or patients with prior malignancy except for adequately treated basal cell carcinoma(s), in situ cervical cancer, or other cancer for which the patient has been disease-free for five or more years)
• •Newly noted clinically significant electrocardiogram (ECG) abnormality
• •Clinically significant abnormal laboratory result that is not consistent with patient's clinical course
• •Active gastrointestinal bleeding resulting in clinically significant hemodynamic changes or a reduction in hemoglobin.
• •Active inflammatory bowel disease (IBD) and/or active gastric or duodenal ulcer disease
• •Has a history of central nervous system (CNS) metastases, seizure disorder or neurological exam finding suggestive of CNS metastases
• •Has Stage B or C liver cirrhosis according to Child-Pugh-Turcotte Classification
• •Has ascites refractory to diuretic therapy
• •Has any contraindication for MRI procedure
• •If female of childbearing potential, has a positive serum HCG
• •If female, is lactating