Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040898
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2002-07-08
Brief Title:
Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma HCC A Phase II Trial With Historical Control
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The Chinese herbal medicine Sho-saiko-to contains ingredients that may slow the growth of tumor cells and stimulate a persons 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
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:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-01002 | None | None | None |
| NCI-G02-2084 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |