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Postoperative oxaliplatin liver‑directed chemotherapy plus drug combination in patients with resected colorectal liver metastases at high risk of recurrence

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

After surgery for colorectal cancer that has spread to the liver metastases, patients may receive a special chemotherapy plan. The plan uses a drug called oxaliplatin that is delivered directly into the liver’s blood supply through a method known as hepatic arterial infusion, while other medicines – fluorouracil, folinic acid, calcium levofolinate and irinotecan – are given by ordinary IV infusion.

The main aim is to see whether this approach can keep the cancer from returning for a longer time, measured as progression-free survival. After the operation, participants are randomly assigned to receive the liver‑directed treatment together with the usual IV chemotherapy, with treatment cycles given every few weeks and regular clinic visits for monitoring.

During the study, patients have routine scans and blood tests to look for any signs of cancer coming back, to check for side effects, and to answer simple questionnaires about overall health and quality of life. Follow‑up continues for several years to record how long patients stay free of disease and to collect safety information.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and assignment

    After surgery, you are assigned to one of the treatment groups by a random process. the assignment determines whether you will receive hepatic arterial infusion of oxaliplatin together with intravenous chemotherapy or another standard approach.

  2. Step 2

    Catheter placement for hepatic arterial infusion

    If you are assigned to the hepatic arterial infusion arm, a thin tube (catheter) is placed into the artery that supplies blood to the liver. this allows the drug to be delivered directly to the liver tissue.

  3. Step 3

    First chemotherapy cycle

    On the day of the first cycle, the following medicines are given:

    oxaliplatin: 85 mg per square meter of body surface area, administered intra‑arterial (through the catheter) or intravenous (through a vein) as specified by the protocol.

    fluorouracil: 2800 mg per square meter, given intravenous.

    folinic acid: 400 mg per square meter, given intravenous.

    calcium levofolinate: 200 mg per square meter, given intravenous.

    irinotecan: 150 mg per square meter, given intravenous.

    The dose unit mg/m2 means the amount of drug is calculated based on your body surface area, which helps adjust the dose to your size.

  4. Step 4

    Repeated chemotherapy cycles

    The same set of medicines is repeated in subsequent cycles. the trial aims for you to receive at least four cycles of oxaliplatin within the first three months.

    Each cycle follows the same dosing schedule described in step 3. the exact interval between cycles (for example, every two weeks) follows the study protocol and is managed by the clinical team.

  5. Step 5

    Regular monitoring and assessments

    Throughout the treatment period, you undergo scheduled visits for safety checks, blood tests, and imaging studies to look for any signs of disease progression.

    Questionnaires about quality of life are completed at defined times to assess how the treatment affects daily living.

    Any side effects are recorded using a standard grading system, and dose adjustments are made if necessary.

  6. Step 6

    Completion of treatment and follow‑up

    After the planned number of cycles is finished, treatment stops and you enter a follow‑up phase.

    Periodic evaluations continue to monitor for recurrence of disease and to assess overall survival, which is the length of time you remain alive after the start of the trial.

    Follow‑up visits may include imaging, laboratory tests, and quality‑of‑life questionnaires as defined by the study schedule.

Who can join the trial?

22 criteria

  • You must sign a written informed consent form, or if you cannot sign, an independent witness you choose must confirm your consent in writing.
  • Your blood tests must show that your liver, kidneys, and bone marrow are working well. This means:
    • Bilirubin (a substance that shows how well the liver clears waste) must be less than 1.5 times the normal upper limit.
    • Aminotransferases (enzymes that rise when the liver is damaged) must be less than 5 times the normal upper limit.
    • Alkaline phosphatase (another liver enzyme) must be less than 5 times the normal upper limit.
    • INR (a test that measures blood clotting) must be less than 1.5.
    • Platelets (cells that help blood clot) must be higher than 100,000 per mm³.
    • Neutrophils (a type of white blood cell that fights infection) must be higher than 1,500 per mm³.
    • If you are a woman who could become pregnant, you must have a negative pregnancy test within 30 days before randomisation and again within 72 hours before the first treatment.
    • You must agree to use reliable birth‑control methods during the study and for the required time after treatment (women: at least 15 months after oxaliplatin and 6 months after fluorouracil/irinotecan; men: at least 12 months after oxaliplatin and 3 months after fluorouracil/irinotecan).
    • You must be willing and able to follow the study schedule, including clinic visits, treatment appointments, laboratory tests, and other required procedures.
    • You must be enrolled in a Social Security system or an equivalent health‑coverage program.
    • You must be 18 years of age or older.
    • Your overall health must be good enough to have an ECOG performance status of 0 or 1 (0 = fully active, 1 = restricted but able to do light work).
    • Your cancer must be confirmed by tissue examination as stage IV colorectal cancer with a proficient mismatch‑repair (pMMR) status.
    • You must have had liver metastases (tumors that spread from the colon or rectum to the liver) surgically removed using a one‑stage, two‑stage, or reverse‑stage procedure.
    • Before surgery, your cancer must have shown a partial shrinkage or at least not grown (stable disease) in response to pre‑operative chemotherapy, according to the RECIST v1.1 criteria.
    • You must have had curative‑intent surgery (R0 or R1 resection) removing four or more liver metastases. R0 means no visible tumor left; R1 means a tiny amount of tumor may remain under the microscope.
    • After surgery, a CT scan performed within four weeks must show no visible (macroscopic) tumor left in the liver or elsewhere, except for up to three very small lung nodules (<10 mm) that can be removed or treated, and a primary tumor that is not causing significant symptoms.
    • You must be eligible for hepatic arterial infusion (HAI) of oxaliplatin, meaning a catheter can be placed in the liver’s blood vessels and there are no medical or technical reasons preventing its use. This includes:
      • No contraindication to oxaliplatin (the chemotherapy drug).
      • No existing peripheral sensory neuropathy (nerve damage) of grade 2 or higher.
      • Suitable blood‑vessel anatomy to allow the catheter placement.
      • Ability to start HAI within eight weeks after surgery and receive at least four treatment cycles, as evaluated by an interventional radiologist and a medical oncologist.

Who cannot join the trial?

24 criteria

  • Stage IV dMMR colorectal cancer – advanced colon cancer with a specific genetic feature that makes it unsuitable for this study.
  • Being pregnant or currently breast‑feeding.
  • Having taken part in another treatment trial within the past 30 days.
  • Having a heart rhythm measurement called the QT/QTc interval that is longer than 450 ms for men or 470 ms for women.
  • Having ongoing side effects from previous treatment that are worse than mild (grade > 1).
  • Having a known allergy (hypersensitivity) to any of the study drugs or their ingredients, including:
    • Allergy to 5‑fluorouracil, especially if you have a serious infection, poor nutrition, recent use of brivudine, live vaccines, significant heart disease, or a heart attack in the past 6 months.
    • Allergy to oxaliplatin if you have severely reduced kidney function (creatinine clearance less than 30 ml/min).
    • Allergy to irinotecan if you have chronic inflammatory bowel disease, a bowel blockage, are taking St John’s Wort, or have received live vaccines.
    • Having already received 6 months of FOLFOX or 3 months of CAPOX chemotherapy after your primary tumor surgery, if that treatment ended less than 6 months ago.
    • Being unable or unwilling to attend the required follow‑up visits because of distance, family, social, or personal reasons.
    • Being under legal guardianship, protective custody, or otherwise deprived of personal freedom.
    • Having incomplete surgery (called R2 resection) or remaining cancer seen on a CT scan taken within 4 weeks after surgery, or having a symptomatic primary tumor that requires a different treatment approach.
    • Having a previous history of colorectal liver metastases that were treated with curative intent.
    • Having conditions that make the study’s liver‑directed (HAI) or intravenous chemotherapy unsafe, such as:
      • Unusual anatomy of the hepatic (liver) artery.
      • Peripheral sensory neuropathy (nerve damage) of grade 2 or higher.
      • Active stomach or duodenal ulcer.
      • Severe chronic liver disease causing portal hypertension or liver failure.
      • Having a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), which affects how certain chemotherapy drugs are processed.
      • Having low levels of key electrolytes:
        • Potassium less than 3.5 mEq/L.
        • Magnesium less than 1.8 mg/dL.
        • Calcium less than 8.8 mg/dL.
        • Having another current or past cancer, except for:
          • In‑situ cervical (uterine) cancer that was adequately treated.
          • Basal or squamous cell skin cancer that was adequately treated.
          • Cancer that has been in complete remission for at least 5 years.
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Investigated drugs

  • Fluorouracil

    is a chemotherapy medicine that stops cancer cells from making the DNA they need to grow. In this trial it is given through a vein (intravenously) after surgery to help kill any remaining cancer cells.

  • Folinic acid

    is a vitamin‑like substance that is used together with fluorouracil. It makes the chemotherapy work better and can also help protect normal cells from side effects.

  • Oxaliplatin

    is a platinum‑based chemotherapy drug. It damages the DNA inside cancer cells, which stops them from dividing. In the study it is delivered directly into the liver’s blood vessels (hepatic arterial infusion) and also given through a vein, aiming to treat any cancer that might be left in the liver after surgery.

  • Calcium levofolinate

    is a form of folate that, like folinic acid, is given with chemotherapy to improve its effectiveness and reduce side effects. It is administered intravenously after the operation.

  • Irinotecan

    is another chemotherapy agent that interferes with the DNA copying process in cancer cells, preventing them from multiplying. It is given through a vein as part of the postoperative treatment plan.

What is already known about the treatment

  • Fluorouracil

    Fluorouracil is given by intravenous infusion and works as an antimetabolite drug that blocks the building blocks needed for DNA, slowing cancer cell growth. It is an established chemotherapy agent widely used in medical practice and described in many clinical studies. The main use is for treating colorectal cancer and other solid tumors. By interfering with DNA synthesis, it helps stop tumor cells from multiplying.

  • Folinic Acid

    Folinic acid is administered intravenously and acts as a folate derivative that supports normal cell function while boosting the effect of fluorouracil. It is a standard supportive medication approved for clinical use and frequently mentioned in oncology literature. It is mainly used together with fluorouracil in colorectal cancer treatment. The drug helps cancer cells take up more fluorouracil, increasing its anti‑cancer activity.

  • Oxaliplatin

    Oxaliplatin can be given by intravenous infusion or directly into the hepatic artery (intra‑arterial) and belongs to the platinum‑based chemotherapy class that creates damage to DNA. It is an approved drug with extensive use in colorectal cancer and is well documented in medical research. Its primary indication is for colorectal cancer, especially when combined with other agents after surgery. The platinum compound forms links in DNA that prevent cancer cells from dividing properly.

  • Calcium Levofolinate

    Calcium levofolinate is delivered by intravenous infusion and functions as a folate analog that enhances the activity of fluorouracil while protecting normal tissues. It is a recognized adjunct medication approved for clinical use and appears in many chemotherapy guidelines. It is mainly used together with fluorouracil in colorectal cancer protocols. By increasing the binding of fluorouracil to its target, it makes the treatment more effective.

  • Irinotecan

    Irinotecan is administered through an intravenous infusion and is classified as a topoisomerase I inhibitor, a type of drug that stops DNA from unwinding correctly. It is an approved chemotherapy drug with a solid record in the medical literature. The drug is primarily used for colorectal cancer, often in combination with other agents. By blocking an enzyme needed for DNA replication, it hinders cancer cells from growing and dividing.

Investigated diseases

  • Colorectal cancer

    a cancer that starts in the colon or rectum, the lower part of the digestive system. It begins when normal cells in the lining of the colon or rectum change and grow uncontrollably. Over time the tumor can grow larger and may spread to nearby tissues. It can also travel through blood or lymph to other parts of the body. The disease often progresses slowly at first and may become more extensive if not removed.

  • Colorectal cancer liver metastases

    secondary tumors that develop in the liver after cancer cells from the colon or rectum travel there. These metastatic spots start as small clusters of cancer cells that grow within liver tissue. As they enlarge, they can affect liver function and may increase in number. The spread usually follows the original colorectal cancer and can happen months or years after the primary tumor is treated. The condition progresses as more liver tissue is involved.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523913-27-00Protocol codeUC-GIG-2515Estimated enrolment272 patientsSponsorUnicancer

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