This is a clinical study to evaluate efficacy of Cytotroic Heterogenous Molecular Lipids (CHML), in patients with advanced or metastatic disease. Response to treatment, duration of response, and survival will be followed.
Patients are treated with 7 mg/kg of CHML, one time per day, 5 to 7 days per week by Intravenous drip (IV), Arterial infusion, local injection, or a combination of these methods.
The majority of patients presenting with irresettable hepatic disease have large tumors within a compromised liver. The main factors responsible for excluding an individual for this therapy are excessive portal vein obstruction and decompensated cirrhosis.
The best therapeutic results are obtained in hypervascular-encapsulated tumors (less than 5 cm diameter), with good underlying liver function. Some tumors are larger than 5 cm in diameter have responded well, but in general, histological studies have shown that complete tumors necrosis is far less likely to occur with lesions larger than 5 cm.
Unencapsulated tumors and large tumors with capsular invasion derive some supply from the portal venous system, which has led to treatment failure with conventional chemoembolization. Based on this fact, segmental delivery may increase penetration of the agent into small peritumoral portal vein radicals.