Colorectal Adenocarcinoma Metastatic in the LiverPhase 2HAIP-6192NCT07764497
Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis
A Phase 2 study testing Floxuridine (FUDR) in people with Colorectal Adenocarcinoma Metastatic in the Liver and Liver Metastasis Colon Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma Metastatic in the Liver, Liver Metastasis Colon Cancer, Liver Metastases From Colorectal Cancer
- What is being tested?
- Floxuridine (FUDR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Dec 2036
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.
- Physically able to tolerate major partial hepatectomy.
- The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.
- Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).
- The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. In the event that two hepatobiliary surgeons cannot agree, a third surgeon will be consulted. Continued discrepancy will result in the patient's case being presented at weekly hepatobiliary conference for consensus opinion. Inoperable metastases are defined as: requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage. * A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.
- Patient's liver metastases must comprise <70% of the liver parenchyma.
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- Female patients of child-bearing age must undergo a pregnancy test and have a negative result.
- A patient must have had prior chemotherapy.
- ECOG PS < 2.
- Within 14 days of registration: o WBC >3X10E9/L; ANC ≥ 1.5X10E9/L; Platelet count >100X10E9/L; INR < 1.5; HGB ≥ 90 g/L; Estimated creatinine clearance ≥30 ml/min (using Cockcroft and Gault formula); Total serum bilirubin <25.6 umol/L.
- Age ≥ 18 years.
- Signed informed consent.
- Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Patients with limited/responding lung metastases on Physician's discretion.
Who cannot join
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).
- Patient may not have received prior treatment with FUDR.
- Active infection, ascites, hepatic encephalopathy.
- Active concurrent malignancies, except a patient's potentially resectable colorectal primary.
- Extrahepatic metastases except for resectable or ablatable lung metastasis.
- Patient must not have obstruction of GI or GU tract.
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- Female patients who are pregnant or lactating.
- Patients may not be receiving any other investigational agents.
- Patients with history of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded (history of stroke or transient ischemic attack within 6 months prior to Day 1).
- Serious or non-healing active wound, ulcer, or bone fracture.
- Chronic daily treatment with aspirin (> 325 mg/d) or nonsteroidal anti- inflammatory medications known to inhibit the platelet function.
- Presence of bleeding diathesis or coagulopathy.
- History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure of > 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e. atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or peripheral vascular disease (Grade II or greater).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Rachel Roke, BSc (Hons.), MSc, 416-480-6100 ext. 685391, rachel.roke@sunnybrook.ca
Paul Karanicolas, MD, PhD
About this study
Official title: A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy in Patients With Inoperable Hepatic Metastasis From Colorectal Cancer
The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.
- Conditions
- Colorectal Adenocarcinoma Metastatic in the Liver, Liver Metastasis Colon Cancer, Liver Metastases From Colorectal Cancer, Liver Metastases of Colorectal Cancer
- Being tested
- Floxuridine (FUDR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floxuridine (FUDR)Drug
Floxuridine will be administered at a recommended dose of 0.12 mg/kg/day and adjusted as per participants weight and lab results.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic arterial infusion pump therapy | Experimental | Hepatic arterial infusion pump therapy with floxuridine (FUDR) and dexamethasone will be administered on Day 1 of each cycle. The pump will be emptied and filled with normal saline on Day 15. Standard of care systemic chemotherapy will be administered on Day 1 and Day 15 as per the treating medical oncologist. Receives: Drug: Floxuridine (FUDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants that undergo liver resection following treatment with FUDR
To assess the rate of conversion to liver resection in patients with initially inoperable hepatic-metastases due to colorectal cancer after treatment with hepatic artery infusion pump therapy and standard of care systemic therapy.
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
Secondary outcomes (6)
Time to disease progression in all participants
To evaluate time to progression (TTP).
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
Time prior to disease progression in all participants
To evaluate disease-free survival (DFS).
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
Time to intrahepatic disease progression in all participants
To evaluate time to disease progression in liver.
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
Time to death in all participants
Overall survival
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
Number of participants with complete response, partial response, progressive disease, or stable disease as per RECIST Version 1.1
To determine the response rate to systemic chemotherapy and FUDR.
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
Number of participants with grade 3 or higher adverse events as per CTCAE Version 4.03
To evaluate the safety and tolerability of hepatic arterial infusion pump therapy and standard of care systemic therapy.
Measured: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startJul 2014
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenocarcinoma Metastatic in the LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764497
- Sponsor's protocol ID
- HAIP-6192
- Acronym
- HAIP-6192
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined on a case by case basis and appropriate participant consent, research ethics board review, and execution of legal agreements.