Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy

PHASE3RecruitingINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

November 21, 2024

Primary Completion Date

January 31, 2030

Study Completion Date

January 31, 2035

Conditions
Colorectal NeoplasmsFloxuridineLiver MetastasesVascular Access Device
Interventions
DRUG

Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy

Floxuridine is administered via the hepatic arterial infusion pump directly to the hepatic artery with a continous flowrate for a period of 2 weeks. Intra arterial infusion of FUDR is combined with systemic therapy (FOLFOX/FOLFIRI) intravenously. Administration of FUDR via the chemopump is every 4 weeks and systemic therapy is administered every 2 weeks.

DEVICE

Hepatic arterial infusion pump (HAIP)

The HAIP (pump) is implanted during surgery combined with resection of the primary tumor before start of induction treatment with Floxuridine and concomitant systemic therapy

DRUG

Systemic therapy (standard of care)

Patient included in the control arm will receive systemic therapy according to standard clinical practice. Induction therapy regimens include: CAPOX (3 weekly) or FOLFOX/FOLFIRI/FOLFOXIRI (2weekly) with optional addition of Bevacizumab (2 weekly)

Trial Locations (1)

1066CX

RECRUITING

Antoni van Leeuwenhoek-Netherland Cancer Institute, Amsterdam

All Listed Sponsors
lead

The Netherlands Cancer Institute

OTHER