Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397222
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Sintilimab Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma a Prospective Single-center Single Arm Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study is conducted to evaluate the efficacy and safety of sintilimab bevacizumab plus Y-90 selective internal radiation therapy SIRT for patients with unresectable intermediate-advanced hepatocellular carcinoma HCC
Detailed Description:
This is a single-center prospective study to evaluate the efficacy and safety of sintilimab bevacizumab plus SIRT Sin-Bev-SIRT in patient with unresectable HCC
23 patients with unresectable intermediate-advanced HCC BCLC BC stage will be enrolled in this study The patients will receive sintilimab 200mg IV Q3W and bevacizumab 75mgkg IV Q3W at 3-7 days after SIRT Sintilimab and bevacizumab will last up to 24 months or until disease progresses intolerable toxicity withdrawal of informed consent loss of follow-up death or other circumstances that require termination of treatment whichever occurs first
The primary end point of this study is Progression free survival PFS per mRECIST The secondary endpoints are PFS per RECIST 11 objective response rate ORR disease control rate DCR overall survival OS and adverse events AEs
23 patients with unresectable intermediate-advanced HCC BCLC BC stage will be enrolled in this study The patients will receive sintilimab 200mg IV Q3W and bevacizumab 75mgkg IV Q3W at 3-7 days after SIRT Sintilimab and bevacizumab will last up to 24 months or until disease progresses intolerable toxicity withdrawal of informed consent loss of follow-up death or other circumstances that require termination of treatment whichever occurs first
The primary end point of this study is Progression free survival PFS per mRECIST The secondary endpoints are PFS per RECIST 11 objective response rate ORR disease control rate DCR 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