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New treatment option for Colorectal Neoplasms
Official title Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy
ClinicalTrials.gov ID: NCT06857773
What this study is testing
What is Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy?
Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Unresectable synchronous CRLM according to a National Liver Panel (CT-scan obtained ≤ 4 weeks prior to registration).
- No extrahepatic metastases. Patients with small (≤ 10 mm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- No previous systemic therapy for colorectal cancer.
You likely can't join if
- Prior hepatic radiation, resection, or ablation.
- Any malignancy, comorbidity or condition that interferes with the planned study treatment or the prognosis of CRLM, determined by the treating...
- History of prior malignancy except for the following: (a) malignancy treated with curative intent and with no evidence of active disease present...
- Obstructive primary tumour requiring emergency surgery, primary tumour necessitating a multivisceral resection/abdominoperineal resection or a rectal...
- MMR deficiency.
- DPD-deficiency.
See the full eligibility criteria
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Unresectable synchronous CRLM according to a National Liver Panel (CT-scan obtained ≤ 4 weeks prior to registration).
- No extrahepatic metastases. Patients with small (≤ 10 mm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- No previous systemic therapy for colorectal cancer.
- Positioning of a catheter for HAIP chemotherapy is technically feasible based on imaging. The default site for the catheter insertion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic arteries are no...
- ECOG performance status 0 or 1.
- Life expectancy of at least 12 weeks.
- Known mutation status of RAS and BRAFV600E.
- Primary tumour in situ and resectable without neoadjuvant therapy.
- Patient is eligible for surgery.
- Patient is eligible for doublet chemotherapy.
- Laboratory requirements: i.e. adequate bone marrow, liver and renal function (obtained within 15 days prior to registration).
- Hb ≥ 5.5 mmol/L
- absolute neutrophil count (ANC) ≥1.5 x 109/L
- platelets ≥100 x 109/L
- total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- ASAT/AST ≤ 5 x ULN
- ALAT/ALT ≤ 5 x ULN
- alkaline phosphatase ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x upper limit of normal or a MDRD (eGFR) ≥ 45 ml/min;
- Prothrombin time or INR \< 1.5 x ULN, unless coumarin derivates are used. All patients using coumarin derivates will be treated with LMWH or DOAC instead.
- Before registration, written informed consent must be given and signed according to ICH/GCP, and national/local regulations.
- Prior hepatic radiation, resection, or ablation.
- Any malignancy, comorbidity or condition that interferes with the planned study treatment or the prognosis of CRLM, determined by the treating physician.
- History of prior malignancy except for the following: (a) malignancy treated with curative intent and with no evidence of active disease present within 3 years prior to inclusion, (b) curatively treated malignancies...
- Obstructive primary tumour requiring emergency surgery, primary tumour necessitating a multivisceral resection/abdominoperineal resection or a rectal tumour requiring preoperative short-course radiotherapy or...
- MMR deficiency.
- DPD-deficiency.
- 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).
- Known serious infections (uncontrolled or requiring treatment).
- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP-SYST or standard systemic therapy.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before...
- Underlying liver disease including liver fibrosis and cirrhosis
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.