Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285019
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-21
Brief Title:
Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Efficacy and Safety of Modified Hepatic Artery Infusion Chemotherapy TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for the First-line Treatment of Advanced Hepatocellular Carcinoma a Prospective Single-arm Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-02
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 single-center single-arm phase II clinical study to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma
Detailed Description:
Hepatocellular carcinoma HCC is one of the most common malignant tumors worldwideThe IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma In addition HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen FOLFOX HAIC in China
The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma Also TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience quality of life and adherence while ensuring the efficacy
In this clinical trial patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar The primary endpoint is overall response rate The secondary endpoint are disease control rate time to progression duration of response overall survival and safety
The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma Also TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience quality of life and adherence while ensuring the efficacy
In this clinical trial patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar The primary endpoint is overall response rate The secondary endpoint are disease control rate time to progression duration of response overall survival and safety
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