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A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM

Liver Metastases Clinical Trial

Official title:
Systemic Chemotherapy With Irinotecan Plus Hepatic Arterial Infusion With Floxuridine and Oxaliplatin in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective Study

Clinical Trial Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin

Clinical Trial Description

Recent studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to determine whether systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03493061
Study type Interventional
Source Sun Yat-sen University
Contact
Status Completed
Phase Phase 2
Start date February 1, 2018
Completion date December 30, 2022
View Details
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