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Brief Title: FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM
Official Title: FUDR/Oxaliplatin HAI Plus Irinotecan Chemotherapy vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM
Study ID: NCT03678428
Brief Summary: The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.
Detailed Description: Previous 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 and FUDR could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to compare objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Name: Yuhong Li, MD
Affiliation: Sun Yat-sen University
Role: STUDY_DIRECTOR