Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control

Conditions
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Liver Cancer

Intervention / Treatment
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* Dietary Supplement: Sho-saiko-to


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Sho-saiko-to|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma