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Study on Regorafenib with Capecitabine, Cyclophosphamide, and Aspirin for Patients with Metastatic Colorectal Cancer Resistant to Chemotherapy

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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 a treatment for metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study is investigating the use of a medication called Regorafenib, which is already used in standard treatments, and comparing it to a new combination therapy. This new combination includes Regorafenib along with other medications: Capecitabine, Cyclophosphamide, and low-dose Aspirin. These medications are taken orally, meaning they are swallowed in the form of tablets or a solution.

The purpose of the study is to see if the combination of these medications can help patients live longer without their cancer getting worse, compared to using Regorafenib alone. Participants in the study will be randomly assigned to receive either the standard treatment with Regorafenib or the new combination therapy. The study will monitor the participants over a period of time to assess how well the treatments work in controlling the cancer and improving the quality of life.

Throughout the study, participants will have regular check-ups and tests to track their health and the progress of their cancer. These tests may include imaging scans like MRI to see how the cancer is responding to the treatment. The study aims to provide valuable information on whether the new combination therapy can offer better outcomes for patients with metastatic colorectal cancer who have not responded well to previous treatments.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide signed and dated informed consent to participate.

    A negative pregnancy test is required for female patients of childbearing potential within 14 days before starting the study medication. Both men and women must use adequate birth control during the study.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes a review of medical history and current health status.

    Tests will be conducted to ensure adequate bone marrow, liver, and kidney functions. This includes checking hemoglobin levels, neutrophil count, platelet count, and other relevant parameters.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving either the standard treatment or the combination treatment.

  4. Step 4

    Treatment phase

    The patient will receive regorafenib in combination with metronomic chemotherapy and low-dose aspirin, or standard regorafenib treatment.

    Medications include Stivarga 40 mg film-coated tablets, Xeloda 500 mg and 150 mg film-coated tablets, KARDEGIC 75 mg oral solution, and ENDOXAN 50 mg coated tablets. All medications are taken orally.

    The dosage and frequency of administration will be determined by the study protocol and the patient's assigned treatment group.

  5. Step 5

    Monitoring and follow-up

    The patient's health and response to treatment will be monitored regularly through medical examinations and imaging tests.

    The primary goal is to assess progression-free survival, which is the time from randomization to disease progression or death from any cause.

  6. Step 6

    Completion of the study

    The study is estimated to end by August 15, 2027. Upon completion, the patient's overall health and treatment outcomes will be evaluated.

    Secondary outcomes such as quality of life, overall survival, and disease control rate will also be assessed.

Who can join the trial?

12 criteria

  • Patients must have **metastatic colorectal cancer** that has been confirmed through a tissue sample. This means the cancer has spread to other parts of the body.
  • The cancer should be getting worse after trying standard treatments, or the patient is not suitable for these treatments. Standard treatments include specific chemotherapy drugs and targeted therapies.
  • There should be no issues with using **iodine contrast media** during a CT scan. This is a special dye used to improve the clarity of the images.
  • Female patients who can have children must have a negative pregnancy test within 14 days before starting the study drug. Both men and women must use effective birth control during the study if applicable.
  • Patients must sign and date an informed consent form, which means they agree to participate in the study after understanding all the details.
  • Patients should be able to follow the study rules and procedures, as judged by the study doctor.
  • Patients must be registered in a national health care system.
  • Patients should have a life expectancy of at least 3 months.
  • Participants must be **18 years or older**.
  • Patients should have a **performance status** of 0 or 1, which means they are fully active or have some restrictions but can still do light work.
  • The disease must be measurable according to specific guidelines, using a scanner or MRI.
  • Patients need to have adequate **bone marrow, liver, and kidney functions**. This includes specific levels of hemoglobin, white blood cells, platelets, bilirubin, liver enzymes, kidney filtration rate, and protein in urine.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
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Investigated drugs

  • Regorafenib

    is a medication used to treat certain types of cancer, including metastatic colorectal cancer. It works by blocking proteins that promote the growth of cancer cells, helping to slow down or stop the progression of the disease.

  • Capecitabine

    is a chemotherapy drug that is used to treat various types of cancer, including colorectal cancer. It is taken orally and works by interfering with the growth of cancer cells, ultimately leading to their destruction.

  • Cyclophosphamide

    is another chemotherapy medication used to treat different types of cancer. It works by slowing or stopping the growth of cancer cells in the body.

  • Aspirin

    is commonly known as a pain reliever and anti-inflammatory medication. In this trial, it is used in low doses to potentially enhance the effects of chemotherapy and improve outcomes for patients with metastatic colorectal cancer.

What is already known about the treatment

Regorafenib – Regorafenib is administered orally in tablet form. It is currently used in the treatment of metastatic colorectal cancer, particularly in cases resistant to standard chemotherapy. The medication works by inhibiting multiple protein kinases, which are involved in tumor growth and angiogenesis, effectively slowing down cancer progression. Regorafenib is classified as a multikinase inhibitor, and its use is well-documented in medical literature for its role in cancer therapy.

Investigated diseases

Metastatic colorectal cancer – This disease occurs when cancer that originated in the colon or rectum spreads to other parts of the body, such as the liver or lungs. It typically begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and spread through the bloodstream or lymphatic system to distant organs. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. The spread of cancer to other organs can complicate treatment and management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509761-21-00Protocol code2023/805Estimated enrolment174 patientsSponsorCentre Hospitalier Regional Universitaire

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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).