Actively Recruiting
Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy
Led by The Netherlands Cancer Institute · Updated on 2025-03-04
306
Participants Needed
1
Research Sites
527 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized clinical trial is to investigate induction treatment with Hepatic Arterial Infusion Pump therapy combined with systemic therapy (HAIP-SYST) in chemotherapy-naive patients with unresectable colorectal liver metastases without extrahepatic disease. The main question it aims to answer is if combined HAIP-SYST improves survival compared to induction treatment with systemic therapy alone. Patients in the control arm will receive systemic therapy according to standard of care. Study procedures experimental arm * Surgery for pump placement and resection of the primary tumor * Pre- and postoperative imaging (CT-anghiography, 99mTc-MAA scintigraphy) * Induction treatment with hepatic arterial infusion pump therapy with Floxuridine combined with systemic therapy Study procedures both arms * Evaluation of resectability status by a National Liver Panel with surgeons and radiologists * Questionnaires for Quality of Life
CONDITIONS
Official Title
Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Unresectable synchronous colorectal liver metastases confirmed by National Liver Panel within 4 weeks prior to registration
- No extrahepatic metastases, except small (10 mm or less) lesions not clearly suspicious for metastases
- No previous systemic therapy for colorectal cancer
- Positioning of catheter for hepatic arterial infusion pump chemotherapy is technically feasible
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Known mutation status of RAS and BRAFV600E
- Primary tumor present and resectable without neoadjuvant therapy
- Eligible for surgery and doublet chemotherapy
- Adequate bone marrow, liver, and renal function within 15 days prior to registration
- Written informed consent given according to regulations
You will not qualify if you...
- Prior hepatic radiation, resection, or ablation
- Any malignancy, comorbidity, or condition interfering with planned treatment or prognosis
- History of prior malignancy except if treated with curative intent and no active disease within 3 years, low risk malignancies, controlled nonmelanomatous skin cancer, or treated carcinoma in situ without disease
- Obstructive primary tumor requiring emergency surgery or complex resections or preoperative radiotherapy
- Mismatch repair deficiency
- DPD deficiency
- Pregnant or lactating women
- Serious systemic disorders compromising safety or study completion
- Organ transplants requiring immunosuppression
- Serious non-healing wounds, ulcers, or bone fractures
- Chronic corticosteroid treatment (10 mg/day or more methylprednisolone equivalent)
- Known serious infections
- Psychiatric disability affecting consent or compliance
- Psychological, familial, sociological, or geographical conditions hampering compliance
- Underlying liver disease including fibrosis and cirrhosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek-Netherland Cancer Institute
Amsterdam, Netherlands, 1066CX
Actively Recruiting
Research Team
K
Koert FD Kuhlmann, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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