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New chemo combo aims to stop liver cancer return after surgery

NCT ID NCT07570914

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The official record

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