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Study on the Effects of Atezolizumab, Bevacizumab, Oxaliplatin, and Capecitabine in Patients with Colorectal Cancer and Liver Metastasis

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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 colorectal cancer that has spread mainly to the liver. The study aims to evaluate the effectiveness and safety of combining several treatments for this condition. The treatments being tested include a standard chemotherapy regimen called XELOX, which is a combination of two drugs, capecitabine and oxaliplatin. Additionally, the study involves the use of targeted therapies, specifically bevacizumab (also known as Avastin) and atezolizumab (also known as Tecentriq or RO5541267), which is an immune checkpoint inhibitor. These treatments are combined with a specialized form of radiation therapy that targets the liver.

The purpose of the study is to assess how well these combined treatments work in preventing the cancer from getting worse over a period of nine months. Participants in the study will receive these treatments through intravenous infusions, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor the participants' health and the progression of their cancer over time to gather information on the effectiveness and any potential side effects of the treatment combination.

This trial is designed to provide valuable insights into the potential benefits of combining chemotherapy, targeted therapy, immunotherapy, and internal radiation therapy for patients with liver-dominant metastatic colorectal cancer. The study is open-label, meaning both the researchers and participants know which treatments are being administered. The ultimate goal is to improve treatment outcomes for patients with this specific type of cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, health status, and specific medical conditions related to colorectal cancer with liver metastasis.

    The assessment ensures that the patient has not received prior treatment for metastatic disease and meets other criteria such as adequate organ function and measurable disease.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of several medications. These include atezolizumab, oxaliplatin, bevacizumab, and capecitabine.

    Atezolizumab is given as an intravenous infusion at a dose of 1,200 mg.

    Oxaliplatin is administered intravenously as a 5 mg/ml solution.

    Bevacizumab is provided as a 25 mg/ml concentrate for infusion.

    Capecitabine is taken orally in the form of 500 mg film-coated tablets.

  3. Step 3

    Treatment schedule

    The medications are administered according to a specific schedule. Intravenous treatments are typically given in cycles, with rest periods in between to allow the body to recover.

    The exact frequency and duration of each medication will be determined by the healthcare team based on individual patient needs and response to treatment.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to evaluate the effectiveness of the treatment and to check for any side effects.

    Progression-free survival is assessed at 9 months using specific criteria to determine the response to treatment.

  5. Step 5

    Completion of trial

    The trial is expected to continue until December 2028. Upon completion, the results will be analyzed to determine the overall efficacy and safety of the treatment combination.

Who can join the trial?

13 criteria

  • Must be over 18 years old.
  • Must have **adequate hematological function**, which means the blood is working well.
  • Must have **adequate hepatic function**, meaning the liver is working well.
  • Must have **adequate renal function**, meaning the kidneys are working well.
  • Must be part of a social security system and have signed a consent form after being informed about the study.
  • Must have a type of colorectal cancer that is **mismatch repair proficient** or **microsatellite stable (MSS)**, which are specific characteristics of the cancer.
  • Must have cancer that mainly affects the liver, with up to 6 other small spots outside the liver, but not in the belly area, and these spots should not cause symptoms or affect organ function.
  • Must have cancer that can be measured using a specific method called **RECIST 1.1**.
  • Must have cancer that cannot be removed by surgery at first, as decided by a team of doctors, and should be suitable for a treatment called **radioembolization** according to a radiologist.
  • The tumor should take up less than 50% of the total liver volume.
  • Must not have had any cancer treatment for the spread of cancer. However, treatment given after surgery or before surgery to the pelvic area is allowed if it was completed at least 6 months before joining the study. Pain relief treatment for cancer spread is allowed except for liver spots and must be finished at least 14 days before joining.
  • Must have a **WHO performance status**, which is a way to measure how well a person can perform daily activities.
  • Must have an estimated life expectancy of at least 3 months.

Who cannot join the trial?

6 criteria

  • Patients with a type of colorectal cancer that is not microsatellite stable (MSS). This means the cancer cells have a specific genetic feature that is not stable.
  • Patients whose cancer has not spread mainly to the liver. This means the cancer should primarily affect the liver.
  • Patients who are not within the specified age range for the study. The study has specific age requirements.
  • Patients who belong to a group that is not included in the study. The study may have specific groups it is focusing on.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are considered part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

  • Selective Internal Radiation Therapy (SIRT)

    is a treatment that involves delivering radiation directly to the liver. It is used to target liver tumors by sending tiny radioactive beads into the blood vessels that supply the tumors. This therapy aims to shrink the tumors and slow their growth.

  • XELOX

    is a combination of two chemotherapy drugs, capecitabine and oxaliplatin. Capecitabine is taken orally and is designed to interfere with the growth of cancer cells, while oxaliplatin is given intravenously and works by damaging the DNA of cancer cells, preventing them from multiplying.

  • Bevacizumab

    is a medication that helps to slow the growth of new blood vessels that tumors need to grow. It is often used in combination with other cancer treatments to enhance their effectiveness by cutting off the blood supply to the tumor.

  • Atezolizumab

    is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking the cancer, thereby boosting the body's natural defenses to fight the cancer.

What is already known about the treatment

  • Bevacizumab

    Bevacizumab is administered intravenously and is used in combination with other medications for treating certain types of cancer, including colorectal cancer with liver-dominant metastasis. It is currently well-established in medical literature as an effective treatment option for various cancers. The main therapeutic indication for Bevacizumab is to inhibit the growth of blood vessels that supply tumors, thereby slowing or stopping tumor growth. At the molecular level, it works by blocking a protein called vascular endothelial growth factor (VEGF), which is essential for the formation of new blood vessels. Bevacizumab is classified as a monoclonal antibody and an angiogenesis inhibitor.

  • Atezolizumab

    Atezolizumab is administered intravenously and is used as an immune checkpoint inhibitor in cancer treatment, including for colorectal cancer with liver-dominant metastasis. It is recognized in medical literature for its role in enhancing the body's immune response against cancer cells. The main therapeutic indication is to help the immune system detect and attack cancer cells more effectively. At the molecular level, Atezolizumab works by blocking the programmed death-ligand 1 (PD-L1) protein, which can prevent the immune system from attacking cancer cells. It is classified as an immune checkpoint inhibitor.

  • XELOX

    XELOX is a combination chemotherapy regimen consisting of capecitabine (Xeloda) and oxaliplatin, administered orally and intravenously, respectively. It is used in the treatment of colorectal cancer, including cases with liver-dominant metastasis. This regimen is well-documented in medical literature as an effective treatment for colorectal cancer. The main therapeutic indication is to kill or stop the growth of cancer cells. Capecitabine is a prodrug that is converted into 5-fluorouracil (5-FU) in the body, which interferes with DNA synthesis, while oxaliplatin forms cross-links in DNA, preventing cell division. XELOX is classified as a chemotherapy regimen.

Investigated diseases

Microsatellite Stable (MSS) Colorectal Cancer with Liver-Dominant Metastasis – This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA repair system is functioning normally. It primarily affects the colon or rectum and has spread predominantly to the liver. The disease progresses as cancer cells grow and multiply, forming tumors in the liver. Over time, these tumors can interfere with liver function and may cause symptoms such as abdominal pain or jaundice. The progression of the disease is monitored through imaging studies to assess tumor size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517204-11-00Protocol codeFFCD 1709 - SIRTCIEstimated enrolment52 patientsSponsorFondation Franc.Cancerologie Digestive

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