Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397235
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
DEB-TACERALOX-HAIC vs DEB-TACE for Large HCC
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma A Single-center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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 study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads DEB-TACE combined with hepatic artery infusion chemotherapy HAIC with oxaliplatin and raltitrexed RALOX-HAIC versus DEB-TACE alone for unresectable large hepatocellular carcinoma HCC
Detailed Description:
This is a single-center randomized study to evaluate the efficacy and safety of DEB-TACE plus RALOX-HAIC DEB-TACEHAIC compared with DEB-TACE alone for unresectable large HCC 7cm
130 patients with unresectable large HCC 7cm will be enrolled in this study The patients will receive either DEB-TACEHAIC or DEB-TACE using an 11 randomization scheme In the DEB-TACEHAIC arm the microcatheter will be reserved at the main hepatic tumor-feeding artery and chemotherapy drugs RALOX-based regimen will be intra-arterially administered though the microcatheter In the DEB-TACE arm patients will be treated with DEB-TACE alone The treatments can be repeated on demand at a 4-week interval usually based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team During follow-up the potential resectability of the tumor will be assessed by the multidisciplinary team MDT Once the tumors become resectable curative surgical resection will be recommended for the patients
The primary end point of this study is progression-free survival PFS The secondary endpoints are tumor response objective response rate and disease control rate overall survival OS and adverse events AEs
130 patients with unresectable large HCC 7cm will be enrolled in this study The patients will receive either DEB-TACEHAIC or DEB-TACE using an 11 randomization scheme In the DEB-TACEHAIC arm the microcatheter will be reserved at the main hepatic tumor-feeding artery and chemotherapy drugs RALOX-based regimen will be intra-arterially administered though the microcatheter In the DEB-TACE arm patients will be treated with DEB-TACE alone The treatments can be repeated on demand at a 4-week interval usually based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team During follow-up the potential resectability of the tumor will be assessed by the multidisciplinary team MDT Once the tumors become resectable curative surgical resection will be recommended for the patients
The primary end point of this study is progression-free survival PFS The secondary endpoints are tumor response objective response rate and disease control rate overall survival OS and adverse events AEs
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