sho-saiko-to following removal of liver cancer by embolization in treating patients with liver cancer that cannot be surgically removed

Conditions: Liver Cancer

Summary: rationale: the chinese herbal medicine sho-saiko-to contains ingredients that may slow the growth of tumor cells and stimulate a person's immune system to help kill tumor cells. this may be an effective treatment following hepatic artery embolization. purpose: phase ii trial to study the effectiveness of sho-saiko-to following hepatic artery embolization in treating patients who have liver cancer.

objectives: * compare the overall survival of patients with unresectable hepatocellular carcinoma treated with sho-saiko-to after ablation therapy with embolization vs historical control patients. * compare the liver function and alpha fetoprotein levels in patients treated with this drug vs historical control patients. * compare the intervention-free survival in patients treated with this drug vs historical control patients. outline: beginning within 1 week after the first course of ablation therapy with embolization, patients receive oral sho-saiko-to three times daily. treatment with sho-saiko-to continues in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 78 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: * one of the following conditions: * histologically confirmed unresectable hepatocellular carcinoma * serum alpha-fetoprotein (afp) level greater than 500 ng/ml with cirrhosis * serum afp level greater than 500 ng/ml with a liver mass and positive hepatitis b or c serology * receiving ablation therapy with embolization * extrahepatic disease allowed * no brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,500/mm\^3 * platelet count greater than 50,000/mm\^3 * hemoglobin greater than 8.0 g/dl hepatic: * see disease characteristics * bilirubin less than 2.0 mg/dl * sgot or sgpt less than 5 times upper limit of normal (uln) * pt or inr less than 1.6 times uln (if not receiving warfarin for anticoagulation) * albumin greater than 2.5 g/dl renal: * creatinine less than 1.8 mg/dl pulmonary: * dlco at least 50% predicted or * dlco at least 70% predicted if total lung capacity less than 80% predicted * no significant lung disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no uncontrolled infection or pain * no other condition that would significantly impair cognitive functioning during the study * no overt psychosis, mental disability, or other incompetency that would preclude study * no other life-threatening illness for which the prognosis is poorer than for hepatocellular carcinoma prior concurrent therapy: biologic therapy: * no concurrent interferon chemotherapy: * no prior chemotherapy within 4 weeks of initiating ablation therapy * no concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy within 4 weeks of initiating ablation therapy * concurrent radiotherapy allowed surgery: * see disease characteristics other: * see disease characteristics * no prior ablation therapy * no other concurrent sho-saiko-to or any of its constituent plants * no other concurrent anticancer medications

Keywords: localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma