NCT02529774

Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer

Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Ye Xu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.

Conditions

• Resected Liver Metastases From Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)	Hepatic Artery Infusion for four cycles: Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion In combination with Systemic Chemotherapy CapeOX for 8 cycles: Oxaliplatin 130 mg/m\^2 iv over 2 hours, Day 1. Capecitabine 850mg/m\^2/d PO Bid, given in the morning and evening, Day 1-14 Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles: Oxaliplatin 85mg/m\^2 IV over 2 hours, Day 1. Leucovorin 400mg/m\^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m\^2 IV and then 2400mg/m\^2 over 48 hours IV continuous infusion. Day 1
DRUG	Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)	Systemic Chemotherapy CapeOX alone for 8 cycles: Oxaliplatin 130 mg/m\^2 iv over 2 hours, Day 1. Capecitabine 850mg/m\^2/d PO Bid, given in the morning and evening, Day 1-14 Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles: Oxaliplatin 85mg/m\^2 IV over 2 hours, Day 1. Leucovorin 400mg/m\^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m\^2 IV and then 2400mg/m\^2 over 48 hours IV continuous infusion. Day 1

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2015-08-20
• Last updated: 2015-08-20

Locations

1 site across 1 country: China