New chemo combo aims to stop liver cancer return after surgery
NCT ID NCT07570914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving chemotherapy directly into the liver along with standard chemo pills and IV drugs can help prevent colorectal cancer from coming back after surgery to remove tumors from the liver. About 28 adults who have had successful surgery and show no remaining cancer will receive up to 4 cycles of this treatment. The goal is to see if this approach improves the chance of staying cancer-free for 3 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 75 years. 2. Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. 3. Histologically confirmed colorectal cancer liver metastases. 4. ECOG performance status of 0 or 1. 5. Expected survival of at least 3 months. 6. Clinical risk score of 3 or higher. 7. Adequate bone marrow function, defined as absolute neutrophil count \>2 × 10\^9/L, hemoglobin \>9.0 g/dL, and platelet count \>100 × 10\^9/L. 8. Adequate renal function, defined as serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula. 9. Adequate hepatic function, defined as serum bilirubin ≤1.5 × the upper limit of normal, transaminases ≤2.5 × the upper limit of normal or ≤5 × the upper limit of normal if liver metastasis is present, and alkaline phosphatase ≤5 × the upper limit of normal. 10. Female participants must not be pregnant or breastfeeding. Women of childbearing potential and male participants must use effective contraception during the study and for 6 months after completion of study treatment. 11. Good compliance, ability to understand the study procedures, and willingness to sign written informed consent. Exclusion Criteria: 1. Contraindication to capecitabine, oxaliplatin, or irinotecan. 2. Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization. 3. Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment. 4. Dihydropyrimidine dehydrogenase deficiency. 5. History of severe cardiovascular disease resulting in inability to tolerate treatment. 6. Peripheral neuropathy greater than Grade 1. 7. History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin. 8. History of allogeneic organ transplantation. 9. Requirement for renal dialysis. 10. Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential. 11. Uncontrolled concomitant disease, including but not limited to severe active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled diabetes, or psychiatric illness that may affect study compliance. 12. Participation in another clinical trial currently or within 4 weeks before enrollment. 13. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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