Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases

Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases - PUMP-IT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55263

Enrollment

Registered

2020-07-10

Start date

2020-09-10

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal adenocarcinoma

Interventions

Surgical implantation of HAIP followed by administration of intra-arterial floxuridine (HAIP chemotherapy) to the liver with concomitant standard systemic FOLFOX (5-FU, leucovorin and oxaliplatin) o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >= 18 years. • ECOG performance status 0 or 1. • Life expectancy of at least 12 weeks. • Histologically confirmed colorectal adenocarcinoma • Indication for first or second line systemic therapy, confirmed in a multidisciplinary meeting. • Potentially resectable (i.e. unresectable and upfront resectable CRLM with indication for neoadjuvant systemic therapy), confirmed in a multidisciplinary meeting and radio-logically on (PET) CT thorax/abdomen and/or MRI obtained = 5.5 mmol/L o Absolute neutrophil count (ANC) >=1.5 * 109/L o Platelets >=100 * 109/L o Total bilirubin 45 ml/min. • Before patient registration, written informed consent must be given and signed accord-ing to ICH-GCP, and national/local regulations.

Exclusion criteria

Exclusion criteria: • Extrahepatic metastases. Confirmed with CT thorax/abdomen obtained = 10 mg/day methylprednisolone equivalent excluding inhaled steroids). • Serious infections (uncontrolled or requiring treatment). • History of psychiatric disability judged by the investigator to potentially hamper com-pliance with the study protocol and follow-up schedule. • Any psychological, familial, sociological or geographical condition potentially hamper-ing compliance with the study protocol and follow-up schedule. • Pregnant or lactating women. • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator. • Organ allografts requiring immunosuppressive therapy. • Serious, non-healing wound, ulcer, or bone fracture. • Chronic treatment with corticosteroids (dose of >= 10 mg/day methylprednisolone equivalent excluding inhaled steroids). • Serious infections (uncontrolled or requiring treatment). • History of psychiatric disability judged by the investigator to potentially hamper compliance with the study protocol and follow-up schedule. • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is feasibility of the HAIP chemotherapy and concomitant systemic chemotherapy. We define this combination feasible if at least 70% of the included patients scheduled for surgery can be treated with at least 2 cycles of HAIP chemotherapy combined with systemic chemotherapy.	—

Secondary

Measure	Time frame
• Safety (surgical complications and chemotherapy toxicity). • Response rates. • Progression Free Survival (PFS). • Overall Survival (OS). • Conversion rates. • Quality of Life (QOL).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)