The PUMP Trial: Chemotherapy for Colorectal Liver Metastases
This study, called The PUMP Trial, is comparing two ways to treat colorectal cancer that has spread to the liver and cannot be removed by surgery. One group of patients will receive standard chemotherapy (like Bevacizumab or Cetuximab, and Fluorouracil) given into a vein. The other group will receive the same standard chemotherapy plus an additional treatment called hepatic arterial infusion (HAI) pump chemotherapy, which delivers Floxuridine directly to the liver. The goal is to see if adding HAI pump chemotherapy improves how long patients live. You may be able to join if you are at least 18 years old and have colorectal cancer that has spread only to your liver and cannot be surgically removed. The study aims to enroll 408 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing two treatment approaches for patients with unresectable colorectal liver metastases. It plans to enroll 408 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Overall survival will be assessed for up to 5 years after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05863195
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
Recruiting
PHASE3Ages 18+InterventionalTreatmentECOG-ACRIN Cancer Research GroupGovernment-funded
~408 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:BevacizumabCetuximabComputed TomographyFloxuridineFluorouracilImplantation
At a glance
Recruiting sites
54 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From randomization to death from any cause, assessed up to 5 years
Conditions
Where it's being run
62 sites across 20 statesPennsylvania8
Florida7
New York6
Missouri5
Texas5
Illinois4
Arizona3
New Jersey3
Study leadership
- Michael Lidsky · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group
Who to contact
Site Public Contact
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Overall survival (OS)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.