Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247728
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2005-11-01
Brief Title:
PI-88 in Hepatocellular Carcinoma After Hepatectomy
Sponsor:
Cellxpert Biotechnology Corp
Organization:
Cellxpert Biotechnology Corp
Study Overview
Official Title:
A Randomized Multi-centre Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy
Detailed Description:
Although early diagnosis and treatment improve survival hepatocellular carcinoma HCC is rarely cured and recurs frequently after regional therapy or transplantation Hepatic resection can improve 5-year recurrence-free survival by up to 25 Micrometastases of HCC have been detected by molecular techniques in 88 of patients at the time of surgery and probably cause postoperative recurrence Efforts to reduce the risk of recurrence after a curative resection have been tried including various regimens of adjuvant and neoadjuvant therapy
In this study an anti-angiogenic agent PI-88 is being used as an adjuvant therapy for HCC patients after curative hepatic resection The efficacy endpoints including tumour non-recurrence rate time to first recurrence and 1-year survival rate are being evaluated Several risk factors associated with tumour recurrence are also being analysed
In this study an anti-angiogenic agent PI-88 is being used as an adjuvant therapy for HCC patients after curative hepatic resection The efficacy endpoints including tumour non-recurrence rate time to first recurrence and 1-year survival rate are being evaluated Several risk factors associated with tumour recurrence are also being analysed
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 |
|---|---|---|---|
| PR88204 | OTHER | Alternate protocol identifier set by company | None |