Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05994859
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-08-09
Brief Title:
SIRT for Potentially Resectable HCC
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma a Prospective Single Arm Trial
Status:
RECRUITING
Status Verified Date:
2023-08
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:
This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy SIRT in patients with potentially resectable hepatocellular carcinoma HCC
Detailed Description:
This is a bi-center prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC
35 patients with potentially resectable initially unresectable HCC will be enrolled in this study The patients will receive 1-2 sessions of SIRT If the patients have invasive tumors extensive liver involvement or vascular invasion systematic treatment will be added If the patients are evaluated as resectable during follw-up liver resection will be recommended
The primary end point of this study is success rate of conversion to resection The secondary endpoints are objective response rate ORR disease control rate DCR progression-free survival PFS time to progression TTP duration of response DOR overall survival OS and adverse events AEs
35 patients with potentially resectable initially unresectable HCC will be enrolled in this study The patients will receive 1-2 sessions of SIRT If the patients have invasive tumors extensive liver involvement or vascular invasion systematic treatment will be added If the patients are evaluated as resectable during follw-up liver resection will be recommended
The primary end point of this study is success rate of conversion to resection The secondary endpoints are objective response rate ORR disease control rate DCR progression-free survival PFS time to progression TTP duration of response DOR overall survival OS and adverse events AEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None