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Study Comparing Regorafenib and Regorafenib-Irinotecan Combination for Patients with Metastatic Colorectal Cancer After Standard Treatments Have Failed

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

This clinical trial is focused on studying metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The trial is testing a combination of two treatments: regorafenib and irinotecan, as well as regorafenib alone. Regorafenib is a medication that comes in the form of a film-coated tablet, while irinotecan is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to compare the overall survival of patients receiving the combination of regorafenib and irinotecan with those receiving regorafenib alone. Participants in the study will be randomly assigned to one of these two treatment groups. The study will last for a maximum of 12 months, during which patients will receive their assigned treatment. The trial aims to understand which treatment option is more effective in extending the life of patients with metastatic colorectal cancer who have a specific genetic makeup known as the A/A genotype of Cyclin D1.

Throughout the study, researchers will monitor various aspects of the patients' health, including their progression-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. Other factors being observed include the time it takes for the patient's condition to deteriorate, the rate at which the disease is controlled, and the overall response to the treatment. The safety of the treatments will also be assessed according to established guidelines, and the quality of life of the participants will be evaluated using a specific questionnaire designed for cancer patients.

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, the patient will be randomly assigned to one of two groups: one receiving a combination of regorafenib and irinotecan, and the other receiving regorafenib alone.

    The study focuses on patients with metastatic colorectal cancer who have not responded to standard treatments.

  2. Step 2

    Medication administration

    Patients in the combination group will receive regorafenib orally in the form of 40 mg film-coated tablets and irinotecan through intravenous infusion.

    Patients in the regorafenib alone group will receive regorafenib orally in the form of 40 mg film-coated tablets.

  3. Step 3

    Treatment schedule

    The treatment will continue until the study's estimated end date of June 30, 2025, or until the patient experiences disease progression or unacceptable side effects.

  4. Step 4

    Monitoring and assessments

    Regular monitoring will be conducted to assess overall survival, progression-free survival, and other health indicators.

    Quality of life will be evaluated using the EORTC QLQ-C30 questionnaire.

  5. Step 5

    End of participation

    Participation in the study will conclude upon reaching the study's end date, or earlier if necessary due to health changes.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of **adenocarcinoma** of the colon or rectum. **Adenocarcinoma** is a type of cancer that forms in mucus-secreting glands.
  • Must have **metastatic colorectal cancer**, meaning the cancer has spread from the colon or rectum to other parts of the body.
  • Cancer must have worsened during or within 3 months after the last treatment with standard therapies. These therapies include specific cancer drugs like **fluoropyrimidine**, **oxaliplatin**, **irinotecan**, **anti-VEGF therapy**, **anti-EGFR therapy** (for certain tumor types), and **encorafenib**.
  • Must have an **ECOG performance status** of 0 or 1. This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
  • Must have a life expectancy of at least 3 months.
  • Must have a specific genetic type called **A/A CCND1 genotype** of **rs603965 CCND1**.
  • Blood tests must show an **International Normalized Ratio (INR)** of 1.5 times the upper limit of normal (ULN) or less, and **partial thromboplastin time (PTT)** or **activated partial thromboplastin time (aPTT)** of 1.5 times the ULN or less, unless receiving treatment with blood thinners. If on blood thinners like heparin, patients can participate if there are no previous issues with these blood tests. Regular monitoring will be done to ensure stability.
  • Open to both male and female participants.
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Investigated drugs

  • Regorafenib

    is a medication used in this trial to treat patients with metastatic colorectal cancer. It works by blocking certain proteins that promote cancer cell growth, helping to slow down or stop the progression of the disease.

  • Irinotecan

    is another medication used in combination with Regorafenib in this trial. It is a type of chemotherapy that interferes with the DNA of cancer cells, preventing them from multiplying and spreading. This combination aims to improve the overall survival of patients with a specific genetic makeup.

What is already known about the treatment

  • Regorafenib

    Regorafenib is taken orally in the form of tablets. It is currently used in the treatment of metastatic colorectal cancer, especially after other standard treatments have failed. The medication works by blocking certain proteins that promote cancer cell growth, effectively slowing down the progression of the disease. It is classified as a multikinase inhibitor, targeting various enzymes involved in tumor growth and angiogenesis.

  • Irinotecan

    Irinotecan is administered intravenously, typically in a hospital or clinical setting. It is used in combination with other drugs to treat metastatic colorectal cancer. The drug works by interfering with the DNA replication process in cancer cells, leading to cell death. Irinotecan is classified as a topoisomerase inhibitor, which helps prevent the cancer cells from multiplying.

Investigated diseases

Metastatic colorectal cancer – This is a type of cancer that begins in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It typically starts 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 organs, and eventually spread through the lymphatic system or bloodstream to distant sites. The progression of the disease can vary, with some patients experiencing rapid spread, while others may have a slower progression. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The disease is often diagnosed at an advanced stage due to its ability to spread before causing noticeable symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512555-21-00Protocol codePROICM 2018-01 NEXEstimated enrolment78 patientsSponsorInstitut Regional Du Cancer De Montpellier

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