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Study on Personalized Treatment for Metastatic Colorectal Cancer Using Regorafenib for Patients with Advanced Disease

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, a type of cancer that has spread from the colon or rectum to other parts of the body. The treatment being tested in this study is a medication called regorafenib, which is taken in the form of film-coated tablets. Regorafenib is a type of drug known as a tyrosine kinase inhibitor, which works by blocking certain proteins that help cancer cells grow.

The purpose of the study is to see if adjusting the dose of regorafenib based on the levels of the drug in the blood can help improve the survival of patients with metastatic colorectal cancer. Participants in the study will be given regorafenib and their blood will be monitored to measure the concentration of the drug and its breakdown products. This will help determine if the drug is being absorbed at an optimal level. The study will compare the outcomes of patients who have optimal levels of the drug in their blood with those who do not.

Throughout the study, participants will take regorafenib tablets and have regular check-ups to monitor their health and the effects of the treatment. The study aims to find out if this personalized approach to dosing can lead to better outcomes for patients. The trial will also look at other factors such as the rate of survival after 10 months, the response of the cancer to the treatment, and any side effects experienced by the participants. The study is expected to continue until 2025.

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, eligibility is confirmed based on specific criteria, including age, medical history, and previous treatments for metastatic colorectal cancer.

    A signed informed consent form is required, and a pre-therapeutic check-up is conducted to ensure adequate bone marrow, renal, and liver function.

  2. Step 2

    Treatment initiation

    The treatment involves taking Stivarga (regorafenib) 40 mg film-coated tablets orally.

    The dosage and frequency are determined by the study protocol, focusing on achieving 'optimal exposure' to the medication.

  3. Step 3

    Monitoring and assessments

    Regular monitoring of plasma concentration of regorafenib and its metabolites is conducted to assess therapeutic levels.

    Patients undergo scheduled visits, laboratory tests, and imaging studies to evaluate treatment response and side effects.

  4. Step 4

    Evaluation of treatment response

    The primary goal is to improve overall survival, with assessments including survival rates, response rates, and disease control rates.

    Progression-free survival and the occurrence of significant side effects are also evaluated.

  5. Step 5

    Completion of study participation

    The study concludes with a final assessment of treatment outcomes and any remaining side effects.

    Patients are monitored for a specified period after discontinuation of the study drug to ensure safety.

Who can join the trial?

14 criteria

  • Male or female patients who are **18 years or older** at the time of signing the Informed Consent Form.
  • Women who can have children and male patients must agree to use **adequate contraception** during the study and for 3 months after finishing the therapy.
  • Women who can have children must have a **negative pregnancy test** within 7 days before starting the study.
  • Patients must be willing and able to follow the **scheduled visits, treatment plan, laboratory tests, and other study procedures**.
  • Patients must be part of the **Social Security System**.
  • Patients must provide a **signed and dated informed consent**.
  • Patients must have **metastatic colorectal cancer** confirmed by a tissue test.
  • Patients must have been previously treated with standard therapies, including specific drugs like **fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF (bevacizumab or aflibercept), and anti-EGFR (cetuximab or panitumumab)** for those with a RAS wild-type tumor.
  • For patients with **MSI-H mCRC**, they must have received **immunotherapy**. For those with a **BRAF mutation**, they should have received a **BRAF inhibitor** if eligible.
  • Patients must have an **ECOG PS** (Eastern Cooperative Oncology Group Performance Status) of 0 or 1, which indicates they are fully active or have some symptoms but do not require bed rest.
  • There must be a **visible imaging target** greater than one centimeter on a CT scan.
  • Patients must have **adequate bone marrow, kidney, and liver function**, as shown by tests done within 7 days before starting the treatment with regorafenib.
  • Patients must have an **INR/PTT** (blood clotting tests) of 1.5 times the upper limit of normal or less.
  • Patients treated with blood-thinning medications like **warfarin or heparin** can participate if there is no previous evidence of abnormal blood clotting. For those on **VKA** (Vitamin K Antagonists), close monitoring with at least weekly checks will be done until the INR/PTT is stable.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with metastatic colorectal cancer. This means the cancer has spread from the colon or rectum to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific health criteria set by the study, which are not detailed here.
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Investigated drugs

Regorafenib is a medication used in this clinical 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. The trial aims to personalize treatment by monitoring the levels of regorafenib in the blood to achieve the best possible outcomes for patients.

What is already known about the treatment

Regorafenib – Regorafenib is administered orally in the form of tablets. It is currently used in the treatment of metastatic colorectal cancer and is well-documented in medical literature for this purpose. The main therapeutic indication for regorafenib is to treat patients with advanced colorectal cancer that has spread to other parts of the body. At the molecular level, regorafenib works by inhibiting multiple protein kinases, which are involved in tumor growth and the development of blood vessels that supply the tumor. It is classified pharmacologically as a multikinase inhibitor.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. The disease 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 organs, and eventually enter the bloodstream or lymphatic system, allowing it to metastasize to distant sites. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of metastatic colorectal cancer can vary, with some patients experiencing rapid spread, while others may have a slower disease course. The focus of treatment often involves managing symptoms and slowing the spread of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517241-13-00Protocol code35RC20_9803_RePERSOEstimated enrolment110 patientsSponsorCentre Hospitalier Universitaire De Rennes

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