Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06059885
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-09-14
Brief Title:
Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC
Sponsor:
Beijing 302 Hospital
Organization:
Beijing 302 Hospital
Study Overview
Official Title:
Tislelizumab Plus Tyrosine Kinase Inhibitor TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation A Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
Background Ablation is important radical treatment in hepatocellular carcinoma HCC However the 5-year recurrence rate of HCC after ablation is up to 80 Early and late recurrences are more likely related to tumor size tumor multiplicity vascular invasion higher serum AFP level and disease etiology etc Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS Adjuvant atezolizumab bevacizumab IMbrave 050 showed RFS improvement following curative resection or ablation Currently there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC This is an open-label prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor TKI as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation
Detailed Description:
None
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