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
Official title: A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial
Is NCT05863195 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments for metastatic colorectal carcinoma.
Treatment: Bevacizumab · Capecitabine · 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
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Colorectal Cancer
Tumor Agnostic
Biomarker criteria
Excluded: MSH2 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: first-line cytotoxic chemotherapy (FOLFOX, FOLFIRI, FOLFOXIRI, bevacizumab, cetuximab, panitumumab) — first-line or adjuvant for stage II-III colorectal cancer
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.
Cannot have received: radiation therapy to the liver
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
Patient must not have had prior trans-arterial bland embolization
Cannot have received: chemoembolization (TACE)
Patient must not have had prior trans-arterial chemoembolization (TACE)
Cannot have received: radioembolization (TARE)
Patient must not have had prior trans-arterial 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
Liver function
Total Bilirubin <= 1.5 mg/dL; AST and ALT <= 3.0 x institutional ULN
Leukocytes >= 3,000/mcL; ANC >= 1,500/mcL; Platelets >= 100,000/mcL; Total Bilirubin <= 1.5 mg/dL; AST and ALT <= 3.0 x institutional ULN; Creatinine <= 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min; Calcium >= institutional 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
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Banner-University Medical Center Phoenix · Phoenix, Arizona
- Banner Boswell Medical Center · Sun City, Arizona
- UCHealth University of Colorado Hospital · Aurora, Colorado
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05863195 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy to the liver, trans-arterial bland embolization, chemoembolization (TACE) disqualifies patients from enrollment.
Are patients with MSH2 alterations eligible?
No. MSH2 microsatellite instability-high is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages