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Liver-Focused chemo after surgery aims to stop cancer return

NCT ID NCT07284394

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether giving chemotherapy directly into the liver artery (HAI) after surgery can prevent cancer from coming back in patients with colorectal cancer that spread to the liver. About 272 high-risk patients will receive either standard IV chemo or HAI chemo plus IV chemo for 3 months. The goal is to see if the targeted approach extends the time before the cancer returns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxaliplatin
What this could lead to
If successful, this approach could significantly lower the chance of liver cancer returning after surgery, improving long-term outcomes for patients at high risk.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The HAI procedure has higher toxicity, and it may not prove superior to standard IV chemo in preventing recurrence.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 272 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2035

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 years and older

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: * Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent * Age \> 18 years * ECOG performance status 0-1 * Histologically confirmed stage IV pMMR CRC * Resected CRLM by one- or two-stage procedures including reverse strategy * Partial Response or Stability Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +/- targeted agent before surgery * Curative-intent ( R0/R1 resection ± local ablation) surgery of 4 or higher CRLM * No macroscopic residual (hepatic or extra-hepatic) disease on postoperative CT scan within 4 weeks after surgery confirmed during local multidisciplinary tumor board (except up to 3 lung nodules \< 10 mm deemed amenable to curative-intent resection/local ablation and non-resected primary tumor with no or mild symptoms) * Eligible to HAI of oxaliplatin by (permanent or selective) catheterization defined as the absence of medical (any contraindication to oxaliplatin administration, mainly residual peripheral sensory neuropathy grade \< 2) and technical (vascular anatomy to perform HAI chemotherapy) contraindications to administer oxaliplatin-based doublet or triplet chemotherapy within 8 weeks from surgery during at least 4 cycles evaluated by interventional radiologist and medical oncologist * Normal liver function (bilirubin \< 1.5 x upper limit of normal values (ULN), aminotransferases \< 5 ULN, alkaline phosphatase \< 5 ULN, International normalized ratio (INR) \< 1.5 ULN, platelets \> 100,000/mm3) * Women of childbearing potential must have a negative pregnancy test done within 30 days before randomisation * Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug * Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures * Patients must be affiliated to a Social Security System (or equivalent) Exclusion Criteria: * Stage IV dMMR CRC * Progressive Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +/- targeted * Incomplete (R2) surgery or residual (hepatic or extrahepatic) disease on postoperative CT scan within 4 weeks after surgery or symptomatic primary tumours in case of reverse strategy * Extra hepatic metastasis disease, except ≤ 3 lung nodules \< 10 mm deemed amenable to curative-intent resection/local ablation and non-resected primary tumor with no or mild symptoms * Impossibility to receive at least 4 postoperative cycles with oxaliplatin * Patients with contraindications for HAI or IV doublet or triplet administration as limiting anatomical variations of hepatic artery, peripheral sensory neuropathy ≥ grade 2 (NCI-CTAE v.5.0), gastric/duodenal ulcer or significant chronic liver disease (resulting in portal hypertension and/or liver failure) * Peripheral neuropathy grade ≥ 2 * Patient with a dihydropyrimidine dehydrogenase deficiency (DPD) * Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥5 years * Pregnant women or women who are breast-feeding * Participation in another therapeutic trial within the 30 days prior to randomisation * Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons * Persons deprived of their liberty or under protective custody or guardianship

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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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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