Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632717
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy With Cisplatin and Fluorouracil in Combination With Lipiodol Embolization in Advanced Hepatocellular Carcinoma - a Prospective Single-arm Phase 2 Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Hepatic artery infusion chemotherapy HAIC is a locoregional therapy commonly used in hepatocellular carcinoma HCC with high response rates and minimal impairment of liver function reported Transarterial chemoembolization TACE and transarterial embolization TAE are also commonly used in HCC with high response rates reported yet carry risks of impairing liver function after repeated embolization with a definitive embolic agent On the other hand lipiodol used in TACETAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the definitive embolic agent This study investigates whether combining HAIC with lipiodol embolization will increase efficacy with good liver function preservation
Detailed Description:
Hepatic artery infusion chemotherapy HAIC is an effective locoregional therapy commonly utilized in hepatocellular carcinoma HCC The rationale for the anti-tumor efficacy of HAIC is to deliver high local concentrations of chemotherapeutic agents to the liver tumor Previous studies on HAIC alone or in combination with other systemic therapies have demonstrated excellent intrahepatic tumor contr rates and survival benefits The investigators have previously conducted a pilot study of HAIC in National Taiwan University Hospital NTUH using cisplatin and 5-fluorouracil and demonstrated a high response rate of 26 in advanced HCC patients In addition to the observed efficacy HAIC does not impair liver function significantly over repeated administration and can be safely given to patients with poor or limited liver reserve
Transarterial chemoembolization TACE and transarterial embolization TAE are the most recognized standard treatment in intermediate-stage HCC and are also commonly utilized in advanced-stage HCC TACE procedure is based on administering a cytotoxic drug mixed with lipiodol followed by definitive embolization of the tumor-feeding arteries by an embolic agent However repeated embolization can impair liver function and jeopardize the chance of patients receiving further salvage treatment Lipiodol used in TACETAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the embolic agent such as Gelfoam Performing embolization with lipiodol alone without an embolic agent may limit detrimental effects on the normal liver and help preserve liver function in patients with HCC
The investigators hypothesize that combining HAIC and transient embolization using lipiodol may have enhanced efficacy compared to HAIC alone In addition the unwanted liver function impairment caused by repeated embolization is alleviated by the characteristic transient embolization effect of lipiodol Thus The investigators propose this prospective single-arm phase 2 pilot study comprising HAIC with cisplatin and 5-fluorouracil in combination with lipiodol embolization to investigate its efficacy and safety in patients with advanced HCC
Transarterial chemoembolization TACE and transarterial embolization TAE are the most recognized standard treatment in intermediate-stage HCC and are also commonly utilized in advanced-stage HCC TACE procedure is based on administering a cytotoxic drug mixed with lipiodol followed by definitive embolization of the tumor-feeding arteries by an embolic agent However repeated embolization can impair liver function and jeopardize the chance of patients receiving further salvage treatment Lipiodol used in TACETAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the embolic agent such as Gelfoam Performing embolization with lipiodol alone without an embolic agent may limit detrimental effects on the normal liver and help preserve liver function in patients with HCC
The investigators hypothesize that combining HAIC and transient embolization using lipiodol may have enhanced efficacy compared to HAIC alone In addition the unwanted liver function impairment caused by repeated embolization is alleviated by the characteristic transient embolization effect of lipiodol Thus The investigators propose this prospective single-arm phase 2 pilot study comprising HAIC with cisplatin and 5-fluorouracil in combination with lipiodol embolization to investigate its efficacy and safety in patients with advanced HCC
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