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Liver pump chemotherapy may boost survival in advanced colorectal cancer

NCT ID NCT05863195

Disease control Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 19, 2026 · Updated 7 times

Summary

This phase 3 trial is testing whether adding a chemotherapy pump that delivers drugs directly to the liver (hepatic arterial infusion, or HAI) can help people with colorectal cancer that has spread to the liver and cannot be removed by surgery. About 408 participants will receive either standard chemotherapy alone or standard chemotherapy plus the HAI pump. The main goal is to see if the combination helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hepatic arterial infusion (HAI) with floxuridine plus standard chemotherapy (including bevacizumab)
What this could lead to
If successful, this could offer a new standard treatment option that improves survival for people with colorectal cancer that has spread to the liver and cannot be surgically removed.
What could go wrong
This is a large phase 3 trial, but adding HAI pump therapy is complex and only available at specialized centers. There is a risk of complications from the pump or catheter, and the added benefit over standard chemotherapy alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 408 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2034

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC). * Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes). * NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study. * Patient may have calcified pulmonary nodules, and/or =\< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =\< 6 mm in maximal axial dimension. * Patient's primary tumor may be in place. * Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer. * NOTE: First-line chemotherapy may have included any of the following regimens as listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan (FOLFIRI) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI), each with or without any of the following: bevacizumab, cetuximab, or panitumumab. * Patient must have stable or responding disease on first-line chemotherapy by RECIST 1.1 criteria * Patient must meet the following criteria for technical unresectability: * A margin-negative resection requires resection of three hepatic veins, both portal veins, or the retrohepatic vena cava OR a resection that leaves less than two adequately perfused and drained segments. * NOTE: Institutional multidisciplinary review is required to confirm unresectability and rule out radiographically positive extrahepatic disease. * Patient must undergo CT angiography (chest/abdomen/pelvis) to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks prior to randomization. * Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and be clinically fit to undergo surgery as determined by the pre-operative evaluation. * Leukocytes \>= 3,000/mcL (obtained =\< 14 days prior to protocol randomization) * Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 14 days prior to protocol randomization) * Platelets \>= 100,000/mcL (obtained =\< 14 days prior to protocol randomization) * Total Bilirubin =\< 1.5 mg/dL (obtained =\< 14 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal (ULN) (obtained =\< 14 days prior to protocol randomization) * Creatinine =\< 1.5 x institutional ULN OR creatinine clearance \>= 50 mL/min calculated by the Cockcroft-Gault method (obtained =\< 14 days prior to protocol randomization) * Calcium \>= institutional lower limit of normal (LLN) * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study Exclusion Criteria: * Patient must not have a liver tumor burden exceeding 70% of total liver volume. * Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization). * Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE). * Patient must not have had prior treatment with HAI/floxuridine (FUDR) * Patient must not have microsatellite instability-high (MSI-H) colorectal cancer. * Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS). * Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture. * Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial. * Patient must not have cirrhosis and/or clinical or radiographic evidence of portal hypertension * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm liver cancer metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal carcinoma Metastatic malignant neoplasm in the liver Stage IV colorectal cancer ajcc V8 Unresectable colorectal carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    54 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Banner Boswell Medical Center

    RECRUITING

    Sun City, Arizona, 85351, United States

    Contact Email: •••••@•••••

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Banner-University Medical Center Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

    Contact Email: •••••@•••••

  • Case Western Reserve University

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke Cancer Center Raleigh

    RECRUITING

    Raleigh, North Carolina, 27609, United States

    Contact Email: •••••@•••••

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Forbes Hospital

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • IU Health North Hospital

    RECRUITING

    Carmel, Indiana, 46032, United States

    Contact Email: •••••@•••••

  • Indiana University/Melvin and Bren Simon Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

    Contact Email: •••••@•••••

  • Jefferson Hospital

    RECRUITING

    Jefferson Hills, Pennsylvania, 15025, United States

  • Lehigh Valley Hospital-Cedar Crest

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Hospital East

    WITHDRAWN

    Shiloh, Illinois, 62269, United States

  • Memorial Sloan Kettering Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Northwestern Medicine Cancer Center Old Irving Park

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Parkland Memorial Hospital

    RECRUITING

    Dallas, Texas, 75235, United States

    Contact Email: •••••@•••••

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Saint Elizabeth Youngstown Hospital

    RECRUITING

    Youngstown, Ohio, 44501, United States

    Contact Email: •••••@•••••

  • Saint Vincent Hospital

    RECRUITING

    Erie, Pennsylvania, 16544, United States

  • Siteman Cancer Center at Christian Hospital

    WITHDRAWN

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    WITHDRAWN

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    WITHDRAWN

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    WITHDRAWN

    St Louis, Missouri, 63129, United States

  • UCHealth University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UM Sylvester Comprehensive Cancer Center at Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    RECRUITING

    Hollywood, Florida, 33021, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    RECRUITING

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • UT Southwestern Clinical Center at Richardson/Plano

    RECRUITING

    Richardson, Texas, 75080, United States

  • UT Southwestern Simmons Cancer Center - RedBird

    RECRUITING

    Dallas, Texas, 75237, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • University of Alabama at Birmingham Cancer Center

    WITHDRAWN

    Birmingham, Alabama, 35233, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • University of Minnesota/Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    WITHDRAWN

    St Louis, Missouri, 63110, United States

  • West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Wexford Health and Wellness Pavilion

    RECRUITING

    Wexford, Pennsylvania, 15090, United States

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