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Safety and feasibility study of hepatic arterial vs IV oxaliplatin in patients with colorectal liver metastases and cholangiocarcinoma (oxaliplatin drug combination)

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

The trial focuses on patients whose cancer has spread to the liver from colorectal cancer (colorectal liver metastases) or who have a type of liver cancer called intrahepatic cholangiocarcinoma. The main medicine being tested is oxaliplatin, a chemotherapy drug that contains platinum. In the study the drug is given either by hepatic arterial infusion, which delivers the medicine directly into the artery that supplies the liver, or by intravenous infusion, which delivers it through a vein. Some participants may also take oral capecitabine, a second chemotherapy taken as a pill, and receive heparin, a medication that helps prevent blood clots, as well as acid‑reducing medicines such as omeprazole or pantoprazole to protect the stomach.

The purpose of the study is to find out whether giving oxaliplatin directly to the liver results in higher drug levels inside the tumor compared with the standard vein method. Participants receive the assigned treatment in repeated cycles, with regular blood draws to measure how much drug is in the bloodstream and occasional small liver tissue samples (biopsies) to check drug levels inside the tumor. The schedule also includes routine safety checks and questionnaires about how they feel.

The trial looks at safety by recording any side effects and at feasibility by noting whether the planned treatments and biopsies can be completed as intended. Overall response of the cancer is evaluated using standard criteria called RECIST, and quality of life is assessed with questionnaires. Information gathered will help determine if the liver‑direct method is a practical and safe option for future treatment.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessments

    After joining the study you will undergo baseline imaging of the liver and other required scans to document the extent of disease.

    Blood tests will be taken to evaluate organ function and to provide reference values for later comparisons.

  2. Step 2

    Oxaliplatin infusion

    You will receive oxaliplatin either through a hepatic arterial infusion (HAI) or an intravenous infusion (IV) according to the study arm you are assigned to.

    The dose for the IV route is 85 mg per square meter of body‑surface area; for the HAI route the study uses either 85 mg/m² or 130 mg/m² as specified in the protocol.

    The medication is given as a single infusion during each treatment cycle.

  3. Step 3

    Heparin administration during infusion

    To reduce the risk of clot formation during the infusion, a solution of heparin will be administered intravenously at the time of the oxaliplatin infusion.

  4. Step 4

    Oral medication regimen

    You will take capecitabine 500 mg film‑coated tablets by mouth according to the schedule given by the study team.

    A proton‑pump inhibitor such as omeprazole or pantoprazole will also be taken orally to protect the stomach, following the prescribed dose and frequency.

  5. Step 5

    Blood sampling for pharmacokinetic analysis

    After each infusion, blood samples will be drawn at predefined times to measure the concentration of platinum in the plasma.

    These samples help determine how the drug is processed in your body.

  6. Step 6

    Liver biopsy

    A small tissue sample from the liver will be obtained after the infusion to assess the amount of platinum that reaches the tumor and surrounding liver tissue.

    The procedure is performed according to the study protocol and safety guidelines.

  7. Step 7

    Repeat treatment cycles

    The sequence of infusion, heparin, oral medications, blood sampling, and liver biopsy will be repeated for each scheduled treatment cycle.

    The number of cycles and the interval between them are defined in the study schedule.

  8. Step 8

    Monitoring for side effects

    Throughout the trial you will be assessed for adverse events using the NCI CTCAE version 6.0 grading system.

    Any side effects will be recorded and managed according to the protocol.

  9. Step 9

    Final evaluations

    At the end of the treatment period a final imaging study will be performed to evaluate tumor response.

    Quality‑of‑life questionnaires (QLQ‑C30 and EQ‑5D) will be completed to assess your overall well‑being.

Who can join the trial?

11 criteria

  • Age: You must be 18 years old or older.
  • ECOG performance status 0–1: This is a simple scale that doctors use to see how well you can carry out everyday activities; a score of 0 or 1 means you are fully active or have only minor limitations.
  • Confirmed diagnosis: You need a diagnosis that has been checked under a microscope showing either intrahepatic cholangiocarcinoma (iCCA) (a type of liver cancer) or colorectal adenocarcinoma with liver metastases (CRLM) (colon or rectal cancer that has spread to the liver).
  • Adequate organ function: Your blood and kidney tests must be within safe ranges:
    • Absolute neutrophil count (a type of white blood cell) at least 1.5 × 10⁹/L
    • White blood cell count at least 2.5 × 10⁹/L
    • Platelet count (helps blood clot) at least 100 × 10⁹/L
    • Estimated glomerular filtration rate (a measure of kidney function) at least 30 ml/min
    • Hemoglobin (the protein that carries oxygen in your blood) at least 5.5 mmol/L
    • Total bilirubin (a substance processed by the liver) no more than 25 µmol/L
    • Written informed consent: You must sign a document that shows you understand the study and agree to take part.
    • Hepatic artery infusion pump (HAIP) or eligibility for a similar procedure: You need to have a working pump placed in the liver’s blood vessel, or be a candidate for a new pump placed through the skin, as decided by a specialist called an interventional radiologist who performs imaging‑guided procedures.

Who cannot join the trial?

12 criteria

  • Extrahepatic metastases – cancer that has spread outside the liver; patients with very small uncertain spots (1 cm or less) or limited nearby lymph node involvement may still be allowed.
  • Organ transplantation requiring immunosuppressive therapy – having had an organ transplant and needing medicines that suppress the immune system.
  • Chronic corticosteroid use greater than 10 mg per day (prednisone equivalent) – regularly taking a high dose of strong anti‑inflammatory steroids.
  • Any condition the doctor feels would not be in the patient’s best interest – any health problem that might make the study unsafe or hard to follow.
  • Known cirrhosis or significant liver disease – scarring of the liver (cirrhosis) or serious liver problems such as advanced fibrosis or portal hypertension (high pressure in the liver’s blood vessels).
  • Prior liver radiation, ablation, or surgery – previous radiation treatment, heat‑based removal, or cutting out part of the liver that could interfere with the study’s liver‑directed therapy.
  • Homozygous DPYD gene variant – a genetic change that can cause severe reactions to certain chemotherapy drugs.
  • Active uncontrolled infection, including cholangitis – a current infection that is not under control, especially infection of the bile ducts.
  • Biliary obstruction not adequately resolved – a blockage of the tubes that carry bile that leads to persistent high bilirubin levels (a yellow pigment) or ongoing cholangitis.
  • Prior oxaliplatin‑based chemotherapy causing toxicity – previous treatment with the drug oxaliplatin that resulted in side effects severe enough that the doctor believes more oxaliplatin would be unsafe.
  • Pregnancy or lactation – being pregnant or breastfeeding.
  • Serious other illnesses or systemic disorders – major health problems that could put the patient at risk or make it difficult to follow the study schedule.
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Investigated drugs

  • Capecitabine

    is an oral chemotherapy drug that the patients took as part of their regular cancer treatment before the study started. In this trial it was used as a background medication, meaning it was not being tested but was allowed because some patients already needed it for their disease. The drug works by turning into another chemotherapy agent inside the body, helping to slow the growth of cancer cells.

  • Oxaliplatin

    is the main drug being studied in this trial. It is given by infusion, either directly into the liver’s blood vessels (hepatic arterial infusion) or into a vein (intravenous). The study compares these two ways of delivering oxaliplatin to see which one puts more of the drug into the liver tumors while still being safe. Oxaliplatin is a chemotherapy agent that contains platinum and damages the DNA of cancer cells, stopping them from multiplying.

  • Heparin

    is an anticoagulant (blood thinner) that was given by infusion to patients during the study. Its purpose was to prevent blood clots that could form when the infusion lines are placed, especially during the hepatic arterial infusion. Heparin does not treat the cancer itself but helps keep the infusion process safe.

  • Omeprazole

    is a medication taken by mouth that reduces stomach acid. In the trial it was allowed as a background treatment for patients who needed protection from stomach irritation or ulcers, which can be a side effect of chemotherapy. By lowering acid, omeprazole helps prevent stomach discomfort during the study.

  • Pantoprazole

    is another acid‑reducing drug taken orally. Like omeprazole, it was permitted as a background therapy for patients who required protection of the stomach lining while receiving chemotherapy. It works by decreasing the amount of acid the stomach makes, helping to avoid irritation or ulcer problems during treatment.

What is already known about the treatment

  • Capecitabine

    This medication comes as a film‑coated tablet taken by mouth. It is an approved chemotherapy drug that is used mainly for colorectal cancer and sometimes other solid tumors. Inside the body it is changed into the active drug 5‑fluorouracil, which blocks the building blocks needed for DNA, stopping cancer cells from growing. It belongs to the antimetabolite class of cancer medicines and is well documented in medical literature.

  • Oxaliplatin

    Provided as a concentrate that is mixed and given through an IV infusion, this drug is a platinum‑based chemotherapy approved for colorectal cancer and other gastrointestinal cancers. It is widely studied and used in clinical practice. The medicine works by attaching to DNA and forming links that prevent the DNA from copying itself, which kills cancer cells. It is classified as a platinum alkylating‑like agent.

  • Heparin sodium

    This is a clear solution for injection given by IV infusion to prevent blood clots. Heparin is a long‑standing, widely used anticoagulant that is approved for many conditions where clotting is a risk. It works by boosting the natural protein antithrombin, which stops clotting factors from forming clots. It belongs to the antithrombotic (anticoagulant) drug class.

  • Omeprazole magnesium

    Available as an oral tablet, this medication is a proton‑pump inhibitor that reduces stomach acid and is sold over the counter and by prescription for heartburn, ulcers, and acid‑related disorders. It is an established drug with many years of safety data. The drug blocks a specific pump in stomach cells that makes acid, lowering the amount of acid released. It is classified as a proton‑pump inhibitor.

  • Pantoprazole sodium

    This drug is taken by mouth as an oral tablet and is also a proton‑pump inhibitor used for heartburn, gastro‑esophageal reflux disease, and ulcer prevention. It is an approved and widely used medication with a solid record in medical literature. It works by inhibiting the same stomach acid pump as other PPIs, reducing acid production. It belongs to the proton‑pump inhibitor class.

Investigated diseases

  • Colorectal liver metastases

    Cancer cells that originated in the colon or rectum travel through the bloodstream and form new tumors in the liver. These secondary tumors can grow larger and multiply over time, increasing the amount of liver tissue that is affected. As they expand, they may interfere with normal liver function and can spread to other parts of the body. The disease typically progresses from a few small nodules to more extensive involvement of the liver.

  • Intrahepatic cholangiocarcinoma

    This is a cancer that starts in the bile‑duct cells located inside the liver. The tumor tends to grow slowly at first, but it can invade surrounding liver tissue and blood vessels. Over time it may spread to nearby lymph nodes and distant organs. The disease course often moves from a localized lesion to more widespread liver involvement.

Trial detailsLast updated 11 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-527509-39-01Estimated enrolment13 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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