Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
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|ClinicalTrials.gov Identifier: NCT00040898|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Dietary Supplement: Sho-saiko-to||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control|
|Study Start Date :||January 2001|
|Primary Completion Date :||January 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040898
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Ronald DeMatteo, MD||Memorial Sloan Kettering Cancer Center|