Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313190
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma HSBRT2402
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Stereotactic Body Radiotherapy With or Without Adjuvant Immunotherapy for Small Hepatocellular Carcinoma An Open-label Randomized Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
HSBRT2402
Brief Summary:
For inoperable small hepatocellular carcinoma HCC stereotactic body radiotherapy SBRT is an effective and safe local treatment Despite satisfactory local control rate the incidence of recurrence out the field remains substantial with 2-year PFS of 319 to 609 Therefore a more effective treatment mode is urgently needed Immune checkpoint inhibitors targeting PD-1PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC Recently the combination of immunotherapy with SBRT has shown promising activity in HCC but its utility in small HCC is unclear The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab an anti-PD-1 antibody in patients with recurrent or residual small HCC
Detailed Description:
A total of 140 patients with recurrent or residual small HCC will be stratified according to tumor diameter 3 vs 3 cm and tumor type recurrent vs residual and randomly assigned 11 to receive stereotactic body radiotherapy SBRT with or without adjuvant sintilimab for 6 cycles 200 mg once every 3 weeks with the first dose within 1 week after the completion of SBRT
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