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Study on Capecitabine and Oxaliplatin for Patients with Advanced or Metastatic Gastrointestinal Cancer with CES1 Variant

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What is this trial about?

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

This clinical trial is focused on studying the effects of two medications, Capecitabine and Oxaliplatin, in patients with a type of cancer known as gastrointestinal carcinoma, which affects the digestive system. The study aims to explore how these medications work in the body, particularly in individuals with a specific genetic variation called CES1 1165–33 C>A. This genetic variation may influence how the body processes the medication, potentially affecting its effectiveness and side effects.

Participants in the study will receive treatment with both Capecitabine, which is taken orally as a tablet, and Oxaliplatin, which is given through an intravenous infusion. The study will monitor how the body absorbs and breaks down these medications over a period of time. Researchers are particularly interested in understanding the differences in medication processing between individuals with the genetic variation and those without it. This information could help tailor treatments to improve outcomes and reduce side effects for patients with gastrointestinal carcinoma.

The study will also look at the occurrence of a side effect known as hand-foot syndrome, which can cause redness, swelling, and pain in the hands and feet. By examining the relationship between the genetic variation and the development of this side effect, the study aims to provide insights that could lead to better management of treatment-related symptoms. The trial is expected to continue until the end of 2026, with the goal of enhancing the understanding of how genetic factors influence the treatment of gastrointestinal carcinoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to sign an informed consent form. This form confirms that you understand the study's requirements and agree to participate.

    You must be at least 18 years old and planned to start treatment with capecitabine and oxaliplatin as part of your standard care. Your doctor will determine if you are fit for this treatment.

  2. Step 2

    Treatment initiation

    Your treatment will begin with the administration of capecitabine and oxaliplatin. Capecitabine is taken orally, while oxaliplatin is given through an intravenous infusion.

    The specific dosage and frequency of these medications will be determined by your healthcare provider based on standard care practices.

  3. Step 3

    Monitoring and assessments

    Throughout the study, you will undergo regular monitoring to assess the effects of the treatment. This includes measuring the levels of certain substances in your blood and urine.

    On the last day of the first cycle of capecitabine administration, specific tests will be conducted to measure the concentration of 5-FU, a substance related to the medication.

  4. Step 4

    Genetic testing

    As part of the study, genetic testing will be performed to identify specific genetic variations that may affect how your body processes the medication.

    This testing will help understand the relationship between your genetic makeup and the treatment's effectiveness and side effects.

  5. Step 5

    Completion of study

    The study is expected to continue until December 31, 2026. Your participation may last until the study's completion or until your doctor decides it is appropriate to stop.

    Upon completion, you will receive information about the study's findings and any relevant results related to your participation.

Who can join the trial?

4 criteria

  • Must be at least 18 years old.
  • Planned to start treatment with two specific cancer drugs: capecitabine and oxaliplatin. These are medications used to treat certain types of cancer.
  • Must be considered fit for treatment with capecitabine and oxaliplatin by the doctor in charge.
  • Must be able to understand and follow the study requirements and be able to read and sign the consent form, which explains the study and confirms your willingness to participate.

Who cannot join the trial?

4 criteria

  • Patients with **locally advanced or metastatic gastro-intestinal carcinoma** cannot participate. This means the cancer has spread beyond the initial location in the digestive system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not either male or female cannot participate, as the study includes both genders.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups who may need special protection or care.
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Investigated drugs

Capecitabine is a medication used in cancer treatment. It is a type of chemotherapy that works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. In this study, researchers are looking at how the body processes capecitabine, especially in people with a specific genetic variant. They are also interested in understanding how this medication might cause a side effect known as hand-foot syndrome, which can cause redness, swelling, and pain on the palms of the hands and soles of the feet.

What is already known about the treatment

Capecitabine – Capecitabine is a medication taken orally in the form of tablets. It is currently used in medicine to treat certain types of cancer, specifically locally advanced or metastatic gastrointestinal carcinoma. The main therapeutic use of capecitabine is to slow or stop the growth of cancer cells. At the molecular level, capecitabine works by being converted into 5-fluorouracil (5-FU) in the body, which then interferes with the DNA synthesis of cancer cells, preventing them from multiplying. It is classified as an antimetabolite, a type of chemotherapy drug.

Investigated diseases

Gastrointestinal Carcinoma – Gastrointestinal carcinoma refers to a group of cancers that affect the digestive system, including the stomach, intestines, and other related organs. These cancers begin when cells in the gastrointestinal tract grow uncontrollably, forming tumors. As the disease progresses, the tumors can invade nearby tissues and organs, potentially spreading to other parts of the body. Symptoms may include difficulty swallowing, weight loss, and abdominal pain. The progression of the disease can vary depending on the specific location and type of carcinoma. Over time, the cancer may lead to complications such as obstruction or bleeding within the digestive tract.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516788-96-00Estimated enrolment66 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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