Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496815
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
The Efficacy and Safety of Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
Status:
NOT_YET_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:
The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy
It will also learn about the safety of donafenib combined with immunotherapy and local therapy
The main questions it aims to answer are
The Objective Response Rate mRecist and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy
The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy
The safety of donafenib combined with immunotherapy and local therapy in the participants
Participants will
Replace the original targeted drug with donafenib 02g bid while continuing immunotherapy and local therapy as previous therapy if have
The observation period was 1 year
It will also learn about the safety of donafenib combined with immunotherapy and local therapy
The main questions it aims to answer are
The Objective Response Rate mRecist and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy
The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy
The safety of donafenib combined with immunotherapy and local therapy in the participants
Participants will
Replace the original targeted drug with donafenib 02g bid while continuing immunotherapy and local therapy as previous therapy if have
The observation period was 1 year
Detailed Description:
This is a single-arm prospective clinical study 32 patients who had previously received a targeted drug in combination with or without immunotherapy local therapy transhepatic arterial embolization chemotherapy TACE hepatic arterial infusion chemotherapy HAIC and had not received donafenib will be enrolled The specific experimental protocol was to replace the original targeted drug with donafenib 02g bid while continuing immunotherapy and local therapy as previous therapyif haveThe observation period was 1 year
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