Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646198
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transjugular Intrahepatic Portosystemic Shunt TIPS Plus Half-dose Donafenib a Kind of Anti-angiogenesis Agents in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension a Prospective Single-arm Phase II Study DoTH Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DoTH
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt TIPS plus half-dose donafenib a kind of anti-angiogenesis agents in advanced hepatocellular carcinoma BCLC-C Stage accompanied by tumor thrombosis-associated portal hypertension
Detailed Description:
This is a prospective single-arm phase II study to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt TIPS plus half-dose donafenib a kind of anti-angiogenesis agents in advanced hepatocellular carcinoma BCLC-C Stage accompanied by tumor thrombosis-associated portal hypertension Subjects who meet the admission criteria will be treated with half-dose donafenib after TIPS until disease progression intolerable toxicity death withdrawal of the patient or the researchers determined that the drug must be discontinued
The primary outcome measure is to evaluate the objective response rate ORR based on mRECIST The secondary outcome measures include the duration of response DOR disease control rate DCR the recurrence rate of portal hypertension-related haemorrhage or ascites the median progression-free survival time mPFS and median overall survival time mOS This study also aims to assess the safety and adverse events
The primary outcome measure is to evaluate the objective response rate ORR based on mRECIST The secondary outcome measures include the duration of response DOR disease control rate DCR the recurrence rate of portal hypertension-related haemorrhage or ascites the median progression-free survival time mPFS and median overall survival time mOS This study also aims to assess the safety and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None