Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-10-13
Brief Title:
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion A Multicenter Phase III Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
To compare the impact on recurrence risk of adjuvant Sintilimab a recombinant fully human anti-PD-1 monoclonal antibody for patients with hepatocellular carcinoma and microvascular invasion MVI after hepatectomy
Detailed Description:
This study is a prospective multicenter open-label randomized controlled clinical trial aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection The patients will be randomly divided into three groups the first group will receive six months of adjuvant therapy with Sintilimab 200 mg every three weeks for a total of 9 cycles the second group will receive one year of adjuvant therapy with Sintilimab 200 mg every three weeks for a total of 18 cycles and the Active surveillance group will be closely followed postoperatively A maximum of one postoperative adjuvant TACE is permitted
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