Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01374750
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2011-04-21
Brief Title:
Efficacy of Sirolimus In Liver Transplantation for Hepatocellular Carcinoma HCC
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
A Randomized Phase Ⅱ Trial With Sirolimus-containing Versus mTOR-inhibitor Free Immunosuppression in Patients Undergoing Living Donor Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Sirolimus
Brief Summary:
The purpose of this study is to evaluate the anti-tumor effect of sirolimus-based immunosuppressive regimen in patients following living donor liver transplantation for hepatocellular carcinoma exceeding Milan criteria with respect to recurrence-free survival
Detailed Description:
The Milan criteria were adopted in most of western countries for deceased donor allocation because they identify a subgroup of candidates with hepatocellular carcinoma HCC for whom transplant results are similar to those in patients transplanted for end- stage liver disease without HCC There is a debate involving expanding the indications beyond the Milan criteria in living donor liver transplantation LDLT Some transplant surgeons argue that despite the poorer results LDLT for advanced HCC may be justified since donors voluntarily accept the risks of donor hepatectomy to dedicate a graft for HCC patients who may otherwise have no effective treatment Especially in Korea where living donor liver transplantation LDLT is commonly performed the expansion of Milan criteria is inevitable Sirolimus is a macrolide antibiotic produced by Streptomyces hygroscopic that has demonstrated potent immunosuppressive activity in a number of studies The efficacy of sirolimus as immunosuppressives has been demonstrated in randomized clinical trials in kidney transplantation The use of sirolimus in liver transplantation is rapidly increasing from the standpoint of reducing the conventional calcineurin inhibitor toxicity Sirolimus emerged as an effective alternative for patients with renal insufficiency related to calcineurin inhibitor toxicity In recent studies no differences have been observed with respect to rejection or major complicationsThe use of sirolimus in transplant patients is associated with a dose-dependent increase in serum cholesterol and triglycerides that may require treatment In recent studies in liver transplant recipients using sirolimus as part of a primary immunosuppressive regimen the occurrence of acute cellular rejection is relatively low There is data suggesting that sirolimus is associated with hepatic artery thrombosis Numerous current studies have shown that sirolimus may have inhibitory effects on the development of cancer Immunosuppressive agent with antineoplastic activity is inherently attractive in the setting of liver transplantation for HCC If sirolimus shows some degree of anti-tumor effect in transplant recipients with advanced HCC the indication of LDLT for advanced HCC can be expandedOur hypothesis is that sirolimus based-regimen will improve the HCC recurrence free survival If sirolimus-based protocol shows better recurrence free survival the indication of LDLT for HCC can be expanded LDLT can be one of the best treatment modalities for advanced HCC The patients with advanced HCC can have benefit by liver transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-1004-052-316 | REGISTRY | H-1004-052-316 | None |