Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498622
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-07
Brief Title:
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma After Radical Surgery With Donafenib in Combination With Envafolimab a Prospective Multicentre Single-arm Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a multi-center single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery
Detailed Description:
Hepatocellular carcinoma HCC is a malignant tumor with high morbidity and mortality Surgical resection is the most important radical treatment However the recurrence rate is high especially in the patients with high risk of recurrence after curative resection How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring
Until now there is no standard postoperative adjuvant therapy Various adjuvant treatment methods including immunotherapy targeted therapy TACE are being studied This study is to explore the efficacy and safety of donafenib in combination with envafolimab treatment in HCC patients who are at high risk of recurrence after curative resection
Until now there is no standard postoperative adjuvant therapy Various adjuvant treatment methods including immunotherapy targeted therapy TACE are being studied This study is to explore the efficacy and safety of donafenib in combination with envafolimab treatment in HCC patients who are at high risk of recurrence after curative resection
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