Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727163
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2022-10-24
Brief Title:
FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
FOLFOX Via Hepatic Artery Infusion Chemotherapy HAI Plus Systemic Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Patients With Initially Unresectable RAS-mutated Colorectal Cancer With Liver Metastases A Prospective Randomized Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-03
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 prospective randomized controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy HAI in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases
Detailed Description:
PRIMARY OBJECTIVES
The goal of this prospective randomized controlled clinical trial is to evaluate the objective remission rate ORR of FOLFOX hepatic artery infusion chemotherapy HAI in combination with irinotecan with or without bevacizumab systemic intravenous chemotherapy versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases
SECONDARY OBJECTIVES
To assess and compare the depth of response DpR R0 surgical resection rate No evidence of disease NED rate progression-free survival PFS overall survival OS recurrence-free survival RFS in resectable patients and safety chemotherapy-related adverse events catheterization-related adverse events surgical complications etc between the two intervention groups
OUTLINE
Patients in the HAI group receive FOLFOX via hepatic artery infusion chemotherapy plus intravenous irinotecan with or without bevacizumab every 14 days while patients in the systemic group receive intravenous FOLFOXIRI regimen with or without bevacizumab every 14 days Patients will receive a maximum of 12 cycles in total before and after surgery unless there is disease progression unacceptable toxicity or if the patient withdraws from the study
The goal of this prospective randomized controlled clinical trial is to evaluate the objective remission rate ORR of FOLFOX hepatic artery infusion chemotherapy HAI in combination with irinotecan with or without bevacizumab systemic intravenous chemotherapy versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases
SECONDARY OBJECTIVES
To assess and compare the depth of response DpR R0 surgical resection rate No evidence of disease NED rate progression-free survival PFS overall survival OS recurrence-free survival RFS in resectable patients and safety chemotherapy-related adverse events catheterization-related adverse events surgical complications etc between the two intervention groups
OUTLINE
Patients in the HAI group receive FOLFOX via hepatic artery infusion chemotherapy plus intravenous irinotecan with or without bevacizumab every 14 days while patients in the systemic group receive intravenous FOLFOXIRI regimen with or without bevacizumab every 14 days Patients will receive a maximum of 12 cycles in total before and after surgery unless there is disease progression unacceptable toxicity or if the patient withdraws from the study
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