Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial

May 13, 2026 updated by: ECOG-ACRIN Cancer Research Group

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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, followed by single photon emission computed tomography/computed tomography (SPECT/CT) on study. Patients then receive floxuridine via the HAI pump on study. Patients also receive one of the following standard chemotherapy regimens per the treating physician: 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 study. Patients also undergo CT scans throughout the trial.

ARM B: Patients receive one of the following standard chemotherapy regimens per the treating physician: FOLFOXIRI (fluorouracil IV, oxaliplatin IV, irinotecan IV, and leucovorin IV), FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV, panitumumab IV, and/or bevacizumab IV on study. Patients also undergo CT scans throughout the trial.

Study Type

Interventional

Enrollment (Estimated)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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        • Withdrawn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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (HAI, floxuridine, standard chemotherapy)
Patients undergo surgery to place the HAI pump, followed by SPECT/CT on study. Patients then receive floxuridine via the HAI pump on study. Patients also receive one of the following standard chemotherapy regimens per the treating physician: FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV and/or panitumumab IV on study. Patients also undergo CT scans throughout the trial.
Biological: Panitumumab
Given IV
Other Names:
  • ABX-EGF
  • ABX-EGF Monoclonal Antibody
  • ABX-EGF, Clone E7.6.3
  • MoAb ABX-EGF
  • Monoclonal Antibody ABX-EGF
  • Vectibix
  • E7.6.3
  • Human IgG2K Monoclonal Antibody
  • MoAb E7.6.3
  • Monoclonal Antibody E7.6.3
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Drug: Leucovorin
Given IV
Other Names:
  • Folinic acid
Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669
Drug: Irinotecan
Given IV
Biological: Cetuximab
Given IV
Other Names:
  • Erbitux
  • IMC-C225
  • Cetuximab Biosimilar CDP-1
  • Cetuximab Biosimilar CMAB009
  • Cetuximab Biosimilar KL 140
  • Chimeric Anti-EGFR Monoclonal Antibody
  • Chimeric MoAb C225
  • Chimeric Monoclonal Antibody C225
Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Names:
  • ST
  • Medical Imaging, Single Photon Emission Computed Tomography
  • Single Photon Emission Tomography
  • single-photon emission computed tomography
  • SPECT
  • SPECT imaging
  • SPECT SCAN
  • SPET
  • tomography, emission computed, single photon
  • Tomography, Emission-Computed, Single-Photon
  • Single-Photon Emission Computed
Procedure: Computed Tomography
Undergo SPECT/CT and/or CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
Drug: Floxuridine
Given via HAI pump
Other Names:
  • 5-Fluorodeoxyuridine
  • 5-Fluorouracil deoxyriboside
  • 5-FUdR
  • FDUR
  • Floxuridin
  • Fluorodeoxyuridine
  • Fluorouridine Deoxyribose
  • Fluoruridine Deoxyribose
  • FUdR
  • WR-138720
  • 2'-Deoxy-5-fluorouridine
  • 5-Fluoro-2'-deoxyuridine
Procedure: Implantation
Undergo surgery to place the HAI pump
Procedure: Intrahepatic Infusion Procedure
Undergo HAI
Other Names:
  • Hepatic Artery Infusion
  • HAI
  • Hepatic Arterial Infusion
  • IHI
  • Intrahepatic Infusion
Active Comparator: Arm B (standard chemotherapy)
Patients receive one of the following standard chemotherapy regimens per the treating physician: FOLFOXIRI, FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV, panitumumab IV, and/or bevacizumab IV on study. Patients also undergo CT scans throughout the trial.
Biological: Panitumumab
Given IV
Other Names:
  • ABX-EGF
  • ABX-EGF Monoclonal Antibody
  • ABX-EGF, Clone E7.6.3
  • MoAb ABX-EGF
  • Monoclonal Antibody ABX-EGF
  • Vectibix
  • E7.6.3
  • Human IgG2K Monoclonal Antibody
  • MoAb E7.6.3
  • Monoclonal Antibody E7.6.3
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody 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
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Drug: Leucovorin
Given IV
Other Names:
  • Folinic acid
Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669
Drug: Irinotecan
Given IV
Biological: Cetuximab
Given IV
Other Names:
  • Erbitux
  • IMC-C225
  • Cetuximab Biosimilar CDP-1
  • Cetuximab Biosimilar CMAB009
  • Cetuximab Biosimilar KL 140
  • Chimeric Anti-EGFR Monoclonal Antibody
  • Chimeric MoAb C225
  • Chimeric Monoclonal Antibody C225
Procedure: Computed Tomography
Undergo SPECT/CT and/or CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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) after initiation of treatment (Arm A = surgery, Arm B = cycle 1, day 1 of chemotherapy). 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to 5 years
Defined according to the Common Terminology Criteria for Adverse Events.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael Lidsky, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2034

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA2222 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2023-02357 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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