Liver Cancer Clinical Trial
Official title:
Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
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.
;
Primary Purpose: Treatment
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