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

Phase 3 Terminated 92 enrolled Sun Yat-sen University

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2018-05-28
Primary completion: 2021-08-31
Completion: 2021-08-31

Publications

Wang DS, Pat Fong W, Wen L, Cai YY, Ren C, Wu XJ, Zhang TQ, Cao F, Zuo MX, Li BK, Zheng Y, Li LR, Chen G, Ding PR, Lu ZH, Zhang RX, Yuan YF, Pan ZZ, Li YH. Safety and efficacy of adjuvant FOLFOX/FOLFIRI with versus without hepatic arterial infusion of floxuridine in patients following colorectal cancer liver metastasectomy (HARVEST trial): A randomized controlled trial. Eur J Cancer. 2025 Jan;214:115154. doi: 10.1016/j.ejca.2024.115154. Epub 2024 Nov 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Floxuridine	Unknown	0.12 mg/kg	Other
Background	5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.	Unknown	2.4 g	—
Background	Irinotecan	Small molecule	180 mg/m2	—
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	180 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications