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Study on Valproic Acid with Bevacizumab and Oxaliplatin/Fluoropyrimidine for Patients with RAS-Mutated Metastatic Colorectal Cancer

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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 a type of cancer known as metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. The study is specifically looking at cases where there is a mutation in a gene called RAS. The trial is testing a combination of treatments to see if they can help patients live longer without the cancer getting worse. The treatments being studied include valproic acid, which is usually used to treat seizures, and a combination of cancer-fighting drugs: bevacizumab, oxaliplatin, and a group of drugs known as fluoropyrimidines.

The purpose of the study is to find out if adding valproic acid to the standard treatment of bevacizumab and oxaliplatin/fluoropyrimidine regimens can improve the time patients live without their cancer progressing. This is compared to using bevacizumab and oxaliplatin/fluoropyrimidine regimens alone. The study will involve patients receiving these treatments over a period of time, with some patients receiving a placebo instead of valproic acid. The treatments are given either as an infusion, which means they are delivered directly into the bloodstream through a vein, or as tablets taken by mouth.

Participants in the study will be monitored regularly to assess how well the treatment is working and to check for any side effects. The study aims to provide valuable information that could lead to better treatment options for patients with metastatic colorectal cancer with RAS mutations. The trial is expected to continue until 2026, with the hope of finding a more effective treatment strategy for this challenging condition.

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

    Initial visit and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.

  2. Step 2

    Screening and eligibility confirmation

    The study team will conduct tests to confirm your eligibility. This includes verifying your diagnosis of colorectal cancer with RAS mutations and ensuring you meet other criteria such as age and health status.

  3. Step 3

    Treatment phase

    You will begin the treatment phase, which involves receiving a combination of medications. These include bevacizumab and oxaliplatin administered through an intravenous infusion, and valproic acid taken orally as a prolonged-release tablet.

    Additionally, you will receive fluorouracil through an intravenous infusion or capecitabine as an oral film-coated tablet. The specific dosage and frequency will be determined by the study team based on your individual needs.

  4. Step 4

    Regular monitoring

    Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to assess the progression of your cancer.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment phase, you will undergo a final evaluation to determine the outcome of the treatment. This will involve similar tests and assessments as during the regular monitoring phase.

  6. Step 6

    Follow-up period

    After completing the treatment, you will enter a follow-up period where the study team will continue to monitor your health and any long-term effects of the treatment. This may involve periodic visits and communication with the study team.

Who can join the trial?

10 criteria

  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
  • Must be at Stage IV of the disease, meaning the cancer has spread to other parts of the body.
  • Must have RAS mutations, which are specific changes in the cancer cells.
  • Must have evidence of the disease that can be measured, either through clinical examination or imaging tests.
  • Must have an ECOG performance status of 0 to 1, which means the patient is fully active or has some symptoms but can carry out light work.
  • Must have a life expectancy of more than 3 months.
  • Must agree to use an acceptable method of contraception if they are a man or a woman who can have children.
  • Must have adequately recovered from any previous surgery, with at least 28 days since the surgery or biopsy before joining the study.
  • Must provide written informed consent, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who do not have a **RAS mutation** in their metastatic colorectal cancer. A **mutation** is a change in the DNA sequence of a gene.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a **vulnerable population**. This term refers to groups of people who may be at a higher risk of harm or exploitation in a clinical trial.
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Investigated drugs

  • Valproic acid

    is a medication that is often used to treat seizures and mood disorders. In this clinical trial, it is being tested to see if it can help improve the effectiveness of cancer treatment when used together with other cancer-fighting drugs. The goal is to see if it can help slow down the progression of colorectal cancer that has spread to other parts of the body.

  • Bevacizumab

    is a medication that works by blocking a protein called VEGF, which helps tumors grow new blood vessels. By stopping this process, bevacizumab can help slow or stop the growth of cancer. In this trial, it is used in combination with other drugs to see if it can help improve treatment outcomes for patients with metastatic colorectal cancer.

  • Oxaliplatin

    is a type of chemotherapy drug that is used to treat colorectal cancer. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this study, oxaliplatin is combined with other medications to see if it can help improve the treatment of colorectal cancer that has spread.

  • Fluoropyrimidine

    refers to a group of chemotherapy drugs that are used to treat various types of cancer, including colorectal cancer. These drugs work by interfering with the DNA and RNA of cancer cells, which can prevent them from growing and multiplying. In this trial, fluoropyrimidine is used alongside other treatments to see if it can help improve the outcomes for patients with metastatic colorectal cancer.

What is already known about the treatment

  • Valproic acid

    Valproic acid is administered orally in the form of tablets or liquid. It is currently being studied in combination with other drugs for its potential to improve outcomes in patients with ras-mutated metastatic colorectal cancer. The main therapeutic indication in this trial is to see if it can help prolong the time patients live without their cancer getting worse. At the molecular level, valproic acid works by affecting certain pathways in cells that can influence cancer growth. It is classified as an anticonvulsant and mood-stabilizing drug, but in this context, it is being explored for its potential anti-cancer properties.

  • Bevacizumab

    Bevacizumab is administered through an intravenous infusion. It is a well-established medication in the treatment of various cancers, including colorectal cancer, and is being used in this trial to assess its effectiveness in combination with other drugs. The main therapeutic indication is to inhibit the growth of blood vessels that supply tumors, thereby slowing cancer progression. Bevacizumab works by blocking a protein called vascular endothelial growth factor (VEGF), which is crucial for new blood vessel formation. It is classified as a monoclonal antibody and an anti-angiogenic agent.

  • Oxaliplatin

    Oxaliplatin is given as an intravenous infusion and is a standard chemotherapy drug used in treating colorectal cancer. In this trial, it is being combined with other medications to evaluate its effectiveness in patients with ras-mutated metastatic colorectal cancer. The main therapeutic indication is to kill cancer cells and prevent them from dividing. At the molecular level, oxaliplatin works by binding to DNA in cancer cells, causing damage that leads to cell death. It is classified as a platinum-based chemotherapy agent.

  • Fluoropyrimidine

    Fluoropyrimidine is administered orally or intravenously, depending on the specific drug formulation used. It is a common chemotherapy treatment for colorectal cancer and is being tested in combination with other drugs in this trial. The main therapeutic indication is to interfere with the DNA and RNA of cancer cells, preventing them from growing and dividing. At the molecular level, fluoropyrimidines mimic the building blocks of DNA, disrupting the replication process. They are classified as antimetabolites, a type of chemotherapy drug.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It 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 lymphatic system or bloodstream to distant organs. The disease often progresses in stages, starting from localized growths to regional spread, and eventually to distant metastasis. 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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516844-25-01Estimated enrolment200 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

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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).