Liver-Focused chemo after surgery aims to stop cancer return
NCT ID NCT07284394
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 272 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2035
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 years and older
- 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: * 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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