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Testen der Pump-Chemotherapie zusätzlich zur Standard-Chemotherapie im Vergleich zur Standard-Chemotherapie allein für Patienten mit nicht resezierbaren kolorektalen Lebermetastasen: Die PUMP-Studie

21. September 2026 aktualisiert von: ECOG-ACRIN Cancer Research Group

Eine randomisierte Phase-III-Studie zur systemischen Therapie mit oder ohne hepatische arterielle Infusion bei inoperablen kolorektalen Lebermetastasen: Die PUMP-Studie

This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVE:

I. To determine if patients with persistently unresectable colorectal liver metastases (CRLM) after treatment with first-line chemotherapy have improved overall survival (OS) with hepatic arterial infusion (HAI) and systemic chemotherapy versus systemic chemotherapy alone.

SECONDARY OBJECTIVES:

I. To determine whether there is a direct association between hepatic progression free survival (hPFS) and overall survival (OS) when patients are treated with HAI combined with systemic chemotherapy for unresectable CRLM.

II To determine the impact on progression free survival (overall, hepatic and extrahepatic) for patients with unresectable CRLM treated with HAI in combination with systemic chemotherapy.

III. To determine objective response rate (ORR) in the liver, defined as the proportion of patients achieving complete or partial response by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1.

IV. To determine the rate of conversion to resectable disease, defined as the proportion of patients who successfully convert from unresectable to resectable status and undergo R0/R1 resection/ablation.

V. To determine the rate in which patients are intended to be treated with HAI but are deemed ineligible at the time of planned pump insertion due to detection of occult extrahepatic disease or unsuitable arterial anatomy (Intra-Operative Ineligibility, IOI).

VI. To determine the extent to which patient and disease-specific factors correlate with short- and long-term risk of HAI-specific complications.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo surgery to place the HAI pump within 6 weeks of randomization, followed by single photon emission computed tomography/computed tomography (SPECT/CT) on study. Patients then receive floxuridine via the HAI pump within 12 weeks of randomization on study. Patients also receive one of the following standard chemotherapy regimens per the treating physician within 16 weeks of randomization: FOLFOX (fluorouracil intravenously [IV], oxaliplatin IV, and leucovorin IV), FOLFIRI (fluorouracil IV, irinotecan IV, and leucovorin IV), or OX/IRI (oxaliplatin IV and irinotecan IV) with or without cetuximab IV and/or panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may have leucovorin omitted from their regimen per institutional standards. Patients also undergo CT and/or magnetic resonance imaging (MRI) scans throughout the trial.

ARM B: Patients receive one of the following standard chemotherapy regimens per the treating physician within 6 weeks of randomization: FOLFOXIRI (fluorouracil IV, oxaliplatin IV, irinotecan IV, and leucovorin IV), FOLFOX IV, FOLFIRI IV, or OX/IRI IV with or without cetuximab IV, panitumumab IV, and/or bevacizumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may receive capecitabine orally (PO) in substitution for fluorouracil at the discretion of the investigator and may have leucovorin omitted from their regimen per institutional standards. Patients also undergo CT and/or MRI scans throughout the trial.

After completion of treatment, patients follow up every 3 months for 2 years and then every 6 months for an additional 3 years.

Studientyp

Interventionell

Einschreibung (Geschätzt)

408

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • Zurückgezogen
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Gilbert, Arizona, Vereinigte Staaten, 85234
        • Rekrutierung
        • Banner MD Anderson Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 602-747-9738
        • Hauptermittler:
          • Rajesh Ramanathan
      • Phoenix, Arizona, Vereinigte Staaten, 85006
        • Rekrutierung
        • Banner-University Medical Center Phoenix
        • Kontakt:
        • Hauptermittler:
          • Rajesh Ramanathan
      • Sun City, Arizona, Vereinigte Staaten, 85351
        • Rekrutierung
        • Banner Boswell Medical Center
        • Kontakt:
        • Hauptermittler:
          • Rajesh Ramanathan
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • Rekrutierung
        • UCHealth University of Colorado Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 720-848-0650
        • Hauptermittler:
          • Alexis D. Leal
    • Florida
      • Aventura, Florida, Vereinigte Staaten, 33180
        • Rekrutierung
        • UM Sylvester Comprehensive Cancer Center at Aventura
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 954-461-2180
      • Coral Gables, Florida, Vereinigte Staaten, 33146
        • Rekrutierung
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
      • Deerfield Beach, Florida, Vereinigte Staaten, 33442
        • Rekrutierung
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
      • Hollywood, Florida, Vereinigte Staaten, 33021
        • Rekrutierung
        • UM Sylvester Comprehensive Cancer Center at Hollywood
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
      • Miami, Florida, Vereinigte Staaten, 33136
        • Rekrutierung
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
      • Miami, Florida, Vereinigte Staaten, 33176
        • Rekrutierung
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
      • Plantation, Florida, Vereinigte Staaten, 33324
        • Rekrutierung
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Hauptermittler:
          • Jashodeep Datta
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Rekrutierung
        • Emory University Hospital/Winship Cancer Institute
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 404-778-1868
        • Hauptermittler:
          • Olumide B. Gbolahan
      • Atlanta, Georgia, Vereinigte Staaten, 30342
        • Rekrutierung
        • Emory Saint Joseph's Hospital
        • Hauptermittler:
          • Olumide B. Gbolahan
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 404-851-7115
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • Rekrutierung
        • University of Chicago Comprehensive Cancer Center
        • Kontakt:
        • Hauptermittler:
          • Ryan Merkow
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Rekrutierung
        • Northwestern University
        • Kontakt:
        • Hauptermittler:
          • Shishir K. Maithel
      • Chicago, Illinois, Vereinigte Staaten, 60641
      • Shiloh, Illinois, Vereinigte Staaten, 62269
        • Zurückgezogen
        • Memorial Hospital East
    • Indiana
      • Carmel, Indiana, Vereinigte Staaten, 46032
        • Rekrutierung
        • IU Health North Hospital
        • Kontakt:
        • Hauptermittler:
          • Anita Turk
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • Rekrutierung
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Kontakt:
        • Hauptermittler:
          • Anita Turk
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536
        • Rekrutierung
        • University of Kentucky/Markey Cancer Center
        • Hauptermittler:
          • Michael J. Cavnar
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 859-257-3379
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • Rekrutierung
        • University of Michigan Rogel Cancer Center
        • Hauptermittler:
          • Benjamin D. Ferguson
        • Kontakt:
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Rekrutierung
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Kontakt:
        • Hauptermittler:
          • Kathleen Y. Butler
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • Rekrutierung
        • University of Minnesota/Masonic Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 612-624-2620
        • Hauptermittler:
          • Ajay Prakash
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Rekrutierung
        • Mayo Clinic in Rochester
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 855-776-0015
        • Hauptermittler:
          • Cornelius A. Thiels
    • Missouri
      • City of Saint Peters, Missouri, Vereinigte Staaten, 63376
        • Zurückgezogen
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Vereinigte Staaten, 63141
        • Zurückgezogen
        • Siteman Cancer Center at West County Hospital
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • Zurückgezogen
        • Washington University School of Medicine
      • St Louis, Missouri, Vereinigte Staaten, 63129
        • Zurückgezogen
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Vereinigte Staaten, 63136
        • Zurückgezogen
        • Siteman Cancer Center at Christian Hospital
    • New Jersey
      • Basking Ridge, New Jersey, Vereinigte Staaten, 07920
        • Rekrutierung
        • Memorial Sloan Kettering Basking Ridge
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
      • Middletown, New Jersey, Vereinigte Staaten, 07748
        • Rekrutierung
        • Memorial Sloan Kettering Monmouth
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
      • Montvale, New Jersey, Vereinigte Staaten, 07645
        • Rekrutierung
        • Memorial Sloan Kettering Bergen
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
    • New York
      • Buffalo, New York, Vereinigte Staaten, 14263
        • Rekrutierung
        • Roswell Park Cancer Institute
        • Hauptermittler:
          • Anuradha Krishnamurthy
        • Kontakt:
      • Commack, New York, Vereinigte Staaten, 11725
        • Rekrutierung
        • Memorial Sloan Kettering Commack
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
      • East White Plains, New York, Vereinigte Staaten, 10604
        • Rekrutierung
        • Memorial Sloan Kettering Westchester
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
      • New York, New York, Vereinigte Staaten, 10065
        • Rekrutierung
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
      • New York, New York, Vereinigte Staaten, 10029
        • Rekrutierung
        • Mount Sinai Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-824-7309
          • E-Mail: CCTO@mssm.edu
        • Hauptermittler:
          • James O. Park
      • Uniondale, New York, Vereinigte Staaten, 11553
        • Rekrutierung
        • Memorial Sloan Kettering Nassau
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hauptermittler:
          • Andrea Cercek
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Rekrutierung
        • Duke University Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 888-275-3853
        • Hauptermittler:
          • Hope E. Uronis
      • Raleigh, North Carolina, Vereinigte Staaten, 27609
        • Rekrutierung
        • Duke Cancer Center Raleigh
        • Hauptermittler:
          • Hope E. Uronis
        • Kontakt:
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27157
        • Rekrutierung
        • Wake Forest University Health Sciences
        • Hauptermittler:
          • Perry Shen
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 336-713-6771
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44106
        • Aktiv, nicht rekrutierend
        • Case Western Reserve University
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Rekrutierung
        • Ohio State University Comprehensive Cancer Center
        • Kontakt:
        • Hauptermittler:
          • Alex B. Blair
      • Youngstown, Ohio, Vereinigte Staaten, 44501
        • Rekrutierung
        • Saint Elizabeth Youngstown Hospital
        • Kontakt:
        • Hauptermittler:
          • Howard M. Gross
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Rekrutierung
        • Oregon Health and Science University
        • Kontakt:
        • Hauptermittler:
          • Skye C. Mayo
    • Pennsylvania
      • Allentown, Pennsylvania, Vereinigte Staaten, 18103
        • Rekrutierung
        • Lehigh Valley Hospital-Cedar Crest
        • Kontakt:
        • Hauptermittler:
          • Tareq Al baghdadi
      • Erie, Pennsylvania, Vereinigte Staaten, 16544
        • Rekrutierung
        • Saint Vincent Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 814-452-5000
        • Hauptermittler:
          • Patrick L. Wagner
      • Jefferson Hills, Pennsylvania, Vereinigte Staaten, 15025
        • Rekrutierung
        • Jefferson Hospital
        • Kontakt:
        • Hauptermittler:
          • Patrick L. Wagner
      • Monroeville, Pennsylvania, Vereinigte Staaten, 15146
        • Rekrutierung
        • Forbes Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-858-7746
        • Hauptermittler:
          • Patrick L. Wagner
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
        • Rekrutierung
        • Fox Chase Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 215-728-4790
        • Hauptermittler:
          • Vanessa Wookey
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
        • Rekrutierung
        • West Penn Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-578-5000
        • Hauptermittler:
          • Patrick L. Wagner
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
        • Rekrutierung
        • Allegheny General Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 877-284-2000
        • Hauptermittler:
          • Patrick L. Wagner
      • Wexford, Pennsylvania, Vereinigte Staaten, 15090
        • Rekrutierung
        • Wexford Health and Wellness Pavilion
        • Kontakt:
        • Hauptermittler:
          • Patrick L. Wagner
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232
        • Rekrutierung
        • Vanderbilt University/Ingram Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-811-8480
        • Hauptermittler:
          • Chandrasekhar Padmanabhan
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75390
        • Rekrutierung
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Kontakt:
        • Hauptermittler:
          • Adam C. Yopp
      • Dallas, Texas, Vereinigte Staaten, 75235
      • Dallas, Texas, Vereinigte Staaten, 75237
        • Rekrutierung
        • UT Southwestern Simmons Cancer Center - RedBird
        • Hauptermittler:
          • Adam C. Yopp
        • Kontakt:
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • Rekrutierung
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Kontakt:
        • Hauptermittler:
          • Adam C. Yopp
      • Richardson, Texas, Vereinigte Staaten, 75080
        • Rekrutierung
        • UT Southwestern Clinical Center at Richardson/Plano
        • Kontakt:
        • Hauptermittler:
          • Adam C. Yopp
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • Rekrutierung
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Kontakt:
        • Hauptermittler:
          • Patrick Varley
      • Madison, Wisconsin, Vereinigte Staaten, 53718
        • Rekrutierung
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Kontakt:
        • Hauptermittler:
          • Patrick Varley

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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 previous first-line chemotherapy that meets 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 measurable disease

  • Patients who have disease progression, in the judgement of the treating multidisciplinary team, are not eligible.

    • This requirement does not apply to patients who developed new colorectal liver metastases within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer

  • 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.
    • NOTE: Patients who are deemed technically resectable but simultaneous biologically unresectable are not eligible.

  • Patient must undergo multiphase imaging of the chest, abdomen, and pelvis inclusive of CT and/or MRI angiography to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 28 days prior to randomization.

    • NOTE: If the patient had remote liver-arterial phase imaging greater than 4 weeks from randomization, then only a single phase (portal venous) intravenous contrasted staging CT and/or MRI of the chest/abdomen/pelvis is required.

  • 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.

  • 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 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.

  • Leukocytes >= 3,000/mcL (obtained =< 28 days prior to protocol randomization)

  • Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 28 days prior to protocol randomization)

  • Platelets >= 100,000/mcL (obtained =< 28 days prior to protocol randomization)

  • Total Bilirubin =< 1.5 mg/dL (obtained =< 28 days prior to protocol randomization)

  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 3.0 x institutional upper limit of normal (ULN) (obtained =< 28 days prior to protocol randomization)

  • Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method (obtained =< 28 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A (HAI, floxuridine, standard chemotherapy)

Patients undergo surgery to place the HAI pump within 6 weeks of randomization, followed by single SPECT/CT on study. Patients then receive floxuridine via the HAI pump within 12 weeks of randomization on study. Patients also receive one of the following standard chemotherapy regimens per the treating physician within 16 weeks of randomization: FOLFOX IV, FOLFIRI IV, or OX/IRI IV with or without cetuximab IV and/or panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may have leucovorin omitted from their regimen per institutional standards. Patients also undergo CT and/or MRI scans throughout the trial.
Arzneimittel: Fluorouracil

Given IV

Andere Namen:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluoruracilum
  • 5 FU
  • 5-Fluor-2,4(1H, 3H)-pyrimidindion
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Karac
  • Fluoruracil
  • Fluoracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Verfahren: Magnetic Resonance Imaging

Undergo MRI

Andere Namen:
  • MRT
  • Magnetresonanz
  • Magnetresonanztomographie-Scan
  • Medizinische Bildgebung, Magnetresonanz / Kernspinresonanz
  • HERR
  • MR-Bildgebung
  • MRT-Untersuchung
  • NMR-Bildgebung
  • NMRI
  • Kernspinresonanztomographie
  • Magnetresonanztomographie (MRT)
  • sMRT
  • Magnetresonanztomographie (Verfahren)
  • MRTs
  • Strukturelle MRT
Biologisch: Panitumumab

Given IV

Andere Namen:
  • ABX-EGF
  • Monoklonaler ABX-EGF-Antikörper
  • ABX-EGF, Klon E7.6.3
  • MoAb ABX-EGF
  • Monoklonaler Antikörper ABX-EGF
  • Vectibix
  • E7.6.3
  • Menschlicher monoklonaler IgG2K-Antikörper
  • MoAb E7.6.3
  • Monoklonaler Antikörper E7.6.3
Arzneimittel: Oxaliplatin

Given IV

Andere Namen:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyclohexan Oxalatoplatin
  • JM-83
  • Oxalatoplatin
  • UVP 54780
  • RP-54780
  • SR-96669
  • SR96669
  • Elplat
  • JM 83
  • JM83
  • RP54780
  • SR 96669
Arzneimittel: Leucovorin

Given IV

Andere Namen:
  • Folsäure
Biologisch: Cetuximab

Given IV

Andere Namen:
  • C225
  • Erbitux
  • IMC-C225
  • Cetuximab-Biosimilar CDP-1
  • Cetuximab-Biosimilar CMAB009
  • Cetuximab-Biosimilar KL 140
  • Chimärer monoklonaler Anti-EGFR-Antikörper
  • Chimärer MoAb C225
  • Chimärer monoklonaler Antikörper C225
  • C-225
  • C 225
  • Cetuximab-cetu
  • Cetuxa
  • ENZ 124
  • ENZ-124
  • ENZ124
Arzneimittel: Irinotecan

Given IV

Arzneimittel: Floxuridine

Given via HAI pump

Andere Namen:
  • 5-Fluordesoxyuridin
  • 5-Fluorouracil-Desoxyribosid
  • 5-FUdR
  • FDUR
  • Floxuridin
  • Fluordesoxyuridin
  • Fluorouridin-Desoxyribose
  • Fluoruridin-Desoxyribose
  • FUdR
  • WR-138720
  • 2'-Desoxy-5-fluoruridin
  • 5-Fluor-2'-desoxyuridin
  • WR 138720
  • WR138720
Verfahren: Computed Tomography

Undergo SPECT/CT and/or CT

Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Verfahren: Implantation

Undergo surgery to place the HAI pump

Verfahren: Intrahepatic Infusion Procedure

Undergo HAI

Andere Namen:
  • Leberarterien-Infusion
  • HAI
  • Hepatische arterielle Infusion
  • IHI
  • Intrahepatische Infusion
Verfahren: Single Photon Emission Computed Tomography

Undergo SPECT/CT

Andere Namen:
  • ST
  • Medizinische Bildgebung, Einzelphotonenemissions-Computertomographie
  • Einzelphotonen-Emissionstomographie
  • Einzelphotonen-Emissions-Computertomographie
  • SPECT
  • SPECT-Bildgebung
  • SPECT-SCAN
  • SPET
  • Tomographie, emissionsberechnet, Einzelphoton
  • Einzelphotonenemission berechnet
Aktiver Komparator: Arm B (standard chemotherapy)

Patients receive one of the following standard chemotherapy regimens per the treating physician within 6 weeks of randomization: FOLFOXIRI IV, FOLFOX IV, FOLFIRI IV, or OX/IRI IV with or without cetuximab IV, panitumumab IV, and/or bevacizumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may receive capecitabine PO in substitution for fluorouracil at the discretion of the investigator and may have leucovorin omitted from their regimen per institutional standards. Patients also undergo CT and/or MRI scans throughout the trial.
Biologisch: Bevacizumab

Given IV

Andere Namen:
  • Avastin
  • AB 215
  • Anti-VEGF
  • Humanisierter monoklonaler Anti-VEGF-Antikörper
  • Monoklonaler Anti-VEGF-Antikörper SIBP04
  • Anti-VEGF-rhuMAb
  • Bevacizumab awwb
  • Bevacizumab-Biosimilar ABP 215
  • Bevacizumab-Biosimilar BEVZ92
  • Bevacizumab-Biosimilar BI 695502
  • Bevacizumab-Biosimilar CBT 124
  • Bevacizumab-Biosimilar CT-P16
  • Bevacizumab-Biosimilar FKB238
  • Bevacizumab-Biosimilar GB-222
  • Bevacizumab-Biosimilar HD204
  • Bevacizumab-Biosimilar HLX04
  • Bevacizumab-Biosimilar IBI305
  • Bevacizumab-Biosimilar LY01008
  • Bevacizumab-Biosimilar MIL60
  • Bevacizumab-Biosimilar Mvasi
  • Bevacizumab-Biosimilar MYL-1402O
  • Bevacizumab-Biosimilar QL 1101
  • Bevacizumab-Biosimilar RPH-001
  • Bevacizumab-Biosimilar SCT501
  • Bevacizumab-Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunglobulin G1 (Mensch-Maus-monoklonaler rhuMAb-VEGF-Gammaketten-Anti-Mensch-Gefäß-Endothelial-Wachstumsfaktor), Disulfid mit Mensch-Maus-monoklonaler rhuMAb-VEGF-Leichtkette, Dimer
  • Mvasi
  • MYL-1402O
  • Rekombinanter humanisierter monoklonaler Anti-VEGF-Antikörper
  • rhuMab-VEGF
  • SCT501
  • SIB 04
  • SIBP-04
  • SIBP04
  • Zirabew
  • Avegra
  • QL1101
  • IBI305
  • Byvasda
  • Bevacizumab-Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab-Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma
  • Alymsys
  • ABP-215
  • ABP215
  • Aybintio
  • Bevacizumab-aybi
  • Bevacizumab-equi
  • Bevacizumab-maly
  • Bevacizumab-onbe
  • CT P16
  • CTP16
  • Äquivalent
  • Onbevzi
  • Avzivi
  • Bevacizumab-Biosimilar MB02
  • Bevacizumab-tnjn
  • FKB 238
  • FKB-238
  • FKB238
  • MB 02
  • MB-02
  • MB02
  • Oyavas
  • PF 06439535
  • PF-06439535
  • PF06439535
  • Bevacizumab-aveg
  • Bevacizumab-byva
  • Bevacizumab-nwgd
  • Jobevne
  • IBI 305
  • IBI-305
Arzneimittel: Fluorouracil

Given IV

Andere Namen:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluoruracilum
  • 5 FU
  • 5-Fluor-2,4(1H, 3H)-pyrimidindion
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Karac
  • Fluoruracil
  • Fluoracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Verfahren: Magnetic Resonance Imaging

Undergo MRI

Andere Namen:
  • MRT
  • Magnetresonanz
  • Magnetresonanztomographie-Scan
  • Medizinische Bildgebung, Magnetresonanz / Kernspinresonanz
  • HERR
  • MR-Bildgebung
  • MRT-Untersuchung
  • NMR-Bildgebung
  • NMRI
  • Kernspinresonanztomographie
  • Magnetresonanztomographie (MRT)
  • sMRT
  • Magnetresonanztomographie (Verfahren)
  • MRTs
  • Strukturelle MRT
Arzneimittel: Capecitabine

Given PO

Andere Namen:
  • Xeloda
  • Ro 09-1978/000
Biologisch: Panitumumab

Given IV

Andere Namen:
  • ABX-EGF
  • Monoklonaler ABX-EGF-Antikörper
  • ABX-EGF, Klon E7.6.3
  • MoAb ABX-EGF
  • Monoklonaler Antikörper ABX-EGF
  • Vectibix
  • E7.6.3
  • Menschlicher monoklonaler IgG2K-Antikörper
  • MoAb E7.6.3
  • Monoklonaler Antikörper E7.6.3
Arzneimittel: Oxaliplatin

Given IV

Andere Namen:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyclohexan Oxalatoplatin
  • JM-83
  • Oxalatoplatin
  • UVP 54780
  • RP-54780
  • SR-96669
  • SR96669
  • Elplat
  • JM 83
  • JM83
  • RP54780
  • SR 96669
Arzneimittel: Leucovorin

Given IV

Andere Namen:
  • Folsäure
Biologisch: Cetuximab

Given IV

Andere Namen:
  • C225
  • Erbitux
  • IMC-C225
  • Cetuximab-Biosimilar CDP-1
  • Cetuximab-Biosimilar CMAB009
  • Cetuximab-Biosimilar KL 140
  • Chimärer monoklonaler Anti-EGFR-Antikörper
  • Chimärer MoAb C225
  • Chimärer monoklonaler Antikörper C225
  • C-225
  • C 225
  • Cetuximab-cetu
  • Cetuxa
  • ENZ 124
  • ENZ-124
  • ENZ124
Arzneimittel: Irinotecan

Given IV

Verfahren: Computed Tomography

Undergo SPECT/CT and/or CT

Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall survival (OS)
Zeitfenster: From randomization to death from any cause, assessed up to 5 years

Patients still living will be censored at the date last known alive. OS will be evaluated using the Kaplan-Meier method, and arms will be compared via a stratified log rank test.
From randomization to death from any cause, assessed up to 5 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression free survival (PFS)
Zeitfenster: From randomization to first observed disease progression at any site, or death from any cause, assessed up to 5 years

Patients still living without disease progression will be censored at the date of last disease assessment. Disease progression will be based on findings from surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months after randomization, defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be analyzed similarly to OS, but with and without stratification for sensitivity.
From randomization to first observed disease progression at any site, or death from any cause, assessed up to 5 years
Hepatic PFS
Zeitfenster: From randomization to first observed disease progression in the liver, or death from any cause, assessed up to 5 years

Patients still living without hepatic disease progression will be censored at the date of last disease assessment. Hepatic disease progression will be based on findings from surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months after randomization, defined by RECIST 1.1.
From randomization to first observed disease progression in the liver, or death from any cause, assessed up to 5 years
Extrahepatic-PFS
Zeitfenster: From randomization to first observed disease progression outside of the liver, or death from any cause, assessed up to 5 years

Patients still living without extrahepatic disease progression will be censored at the date of last disease assessment. Extrahepatic disease progression will be based on findings from surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months after randomization, defined by RECIST 1.1.
From randomization to first observed disease progression outside of the liver, or death from any cause, assessed up to 5 years
Objective response rate
Zeitfenster: Up to 5 years

Will assess hepatic disease burden specifically. Defined as the proportion of patients achieving complete or partial response by RECIST 1.1. Response will be based on surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months (+/- 2 weeks) from randomization. Arms will be compared via a Pearson chi-square test. All rates will be reported with exact binomial 95% confidence intervals.
Up to 5 years
Rate of conversion to resectable disease
Zeitfenster: Up to 5 years

Defined as the proportion of patients who successfully convert from unresectable to resectable status and undergo R0/R1 resection/ablation. All rates will be reported with exact binomial 95% confidence intervals.
Up to 5 years
Intra-operative ineligibility rate
Zeitfenster: Up to 5 years

Defined as the proportion of patients intended to receive hepatic arterial infusion that do not undergo pump implantation due to intraoperative detection of occult extrahepatic disease or unsuitable hepatic arterial anatomy. All rates will be reported with exact binomial 95% confidence intervals.
Up to 5 years
Incidence of adverse events
Zeitfenster: Up to 5 years

Defined according to the Common Terminology Criteria for Adverse Events.
Up to 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ECOG-ACRIN Cancer Research Group

Ermittler

  • Hauptermittler: Michael Lidsky, ECOG-ACRIN Cancer Research Group

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. April 2024

Primärer Abschluss (Geschätzt)

30. Juni 2029

Studienabschluss (Geschätzt)

30. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

9. Mai 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Mai 2023

Zuerst gepostet (Tatsächlich)

17. Mai 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EA2222
  • U10CA180820 (US NIH Stipendium/Vertrag)
  • EA2222 (Andere Kennung: CTEP)
  • NCI-2023-02357 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • EA2222 (Andere Kennung: ECOG-ACRIN Cancer Research Group)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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