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Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases. - The PUMP-IT study
EU CTIS ID: 2024-515525-28-00
What this study is testing
The primary objective of the study is feasibility of the HAIP chemotherapy and concomitant systemic chemotherapy (i.e. FOLFOX and FOLFIRI) in patients with liver limited CRC in 2 centers in the Netherlands.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years.
- Adequate bone marrow, liver and renal function as assessed by the following labora-tory requirements to be conducted within 15 days prior to inclusion: o Hb ≥ 5.5 mmol/L o Absolute neutrophil count (ANC) ≥1.5 * 109/L o Platelets ≥100 * 109/L o Total bilirubin < 1.5 mg/dL o ASAT ≤ 5 * times the upper limit of normal (ULN) o ALAT ≤ 5 * ULN o Alkaline phosphatase ≤ 5 * ULN o (estimated) glomerular filtration rate (eGFR) > 45 ml/min.
- Before patient registration, written informed consent must be given and signed accord-ing to ICH-GCP, and national/local regulations
- ECOG performance status 0 or 1.
- Life expectancy of at least 12 weeks.
- Histologically confirmed colorectal adenocarcinoma
You likely can't join if
- Extrahepatic metastases. Confirmed with CT thorax/abdomen obtained ≤ 4 weeks prior to registration. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equiv-alent excluding inhaled steroids).
- Serious infections (uncontrolled or requiring treatment).
- History of psychiatric disability judged by the investigator to potentially hamper compli-ance 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.
- Prior hepatic radiation, resection (other than biopsy), or ablation.
See the full eligibility criteria
Who can join
- Age ≥ 18 years.
- Adequate bone marrow, liver and renal function as assessed by the following labora-tory requirements to be conducted within 15 days prior to inclusion: o Hb ≥ 5.5 mmol/L o Absolute neutrophil count (ANC) ≥1.5 * 109/L o Platelets ≥100 * 109/L o Total bilirubin < 1.5 mg/dL o ASAT ≤ 5 * times the upper limit of normal (ULN) o ALAT ≤ 5 * ULN o Alkaline phosphatase ≤ 5 * ULN o (estimated) glomerular filtration rate (eGFR) > 45 ml/min.
- Before patient registration, written informed consent must be given and signed accord-ing to ICH-GCP, and national/local regulations
- 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 ≤ 4 weeks prior to regis-tration.
- Positioning of a catheter for HAIP chemotherapy is technically feasible confirmed in the multidisciplinary liver meeting based on imaging. The default site for the catheter inser-tion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic arteries are no contra-indication for catheter implantation. The GDA should have at least one branch to the liver, accessory or aberrant hepatic arteries should be ligated to allow for cross perfusion to the entire liver through intrahepatic shunts.
- Indication and eligibility for abdominal surgery confirmed in a multidisciplinary meeting, e.g. primary tumour resection, stoma revision/reversal and diagnostic surgery.
- In case of primary tumour in situ: tumour should be (potentially) resectable, confirmed in a multidisciplinary meeting.
What rules you out
- Extrahepatic metastases. Confirmed with CT thorax/abdomen obtained ≤ 4 weeks prior to registration. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equiv-alent excluding inhaled steroids).
- Serious infections (uncontrolled or requiring treatment).
- History of psychiatric disability judged by the investigator to potentially hamper compli-ance 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.
- Prior hepatic radiation, resection (other than biopsy), or ablation.
- Concurrent malignancies that interfere with the planned study treatment or the progno-sis of CRLM.
- Participation in other clinical trials interfering with the study treatment as judged by the treating physician.
- Dihydropyrimidine dehydrogenasedeficiency (DPD deficiency).
- Pregnant or lactating women.
- Serious concomitant systemic disorders that would compromise the safety of the pa-tient 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.