NCT03500874

Adjuvant Systemic Chemotherapy With or Without HAI-FUDR in Patients With Resected CRLM

Adjuvant Systemic Chemotherapy With or Without Hepatic Arterial Infusion Using Floxuridine in Patients Following Colorectal Cancer Liver Metastases Resection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Detailed description

Numerous retrospective studies have indicated a positive synergistic effect of combining adjuvant oxaliplatin/irinotecan-based doublet systemic chemotherapy and hepatic arterial infusion (HAI) for colorectal cancer (CRC) patients following colorectal cancer liver metastases (CRLM) resection. However, this strategy has not been evaluated prospectively to date. HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Conditions

• Colorectal Cancer
• Liver Metastases
• HAI

Interventions

Type	Name	Description
DRUG	FUDR	Floxuridine(FUDR) 0.12 mg/kg/day，on Day 1-14 through the HAI pump.
DRUG	Oxaliplatin	Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.
DRUG	Leucovorin	Leucovorin 200mg/m2 ivd over 2 hours on Day 1
DRUG	5FU	5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
DRUG	Irinotecan	Irinotecan 180mg/m2

Timeline

• Start date: 2018-05-28
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2018-04-18
• Last updated: 2024-01-22

Locations

1 site across 1 country: China