OncoMatch/Clinical Trials/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
Is NCT05863195 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for metastatic colorectal carcinoma.
Treatment: Bevacizumab · Cetuximab · Floxuridine · Fluorouracil · Irinotecan · Leucovorin · Oxaliplatin · Panitumumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Tumor Agnostic
Biomarker criteria
Excluded: MSI1 microsatellite instability-high
Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy (FOLFOX, FOLFIRI, FOLFOXIRI, bevacizumab, cetuximab, panitumumab) — first-line
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.
Cannot have received: radiation therapy
Exception: prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization
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).
Cannot have received: trans-arterial bland embolization, chemoembolization (TACE), or radioembolization (TARE)
Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).
Cannot have received: HAI/floxuridine (FUDR) (floxuridine)
Patient must not have had prior treatment with HAI/floxuridine (FUDR)
Lab requirements
Blood counts
Leukocytes >= 3,000/mcL; ANC >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine <= 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min (Cockcroft-Gault)
Liver function
Total Bilirubin <= 1.5 mg/dL; AST/ALT <= 3.0 x institutional ULN
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) AST/ALT <= 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- UCHealth University of Colorado Hospital · Aurora, Colorado
- UM Sylvester Comprehensive Cancer Center at Aventura · Aventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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