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Study of Durvalumab with Drug Combination for Patients with Locally Advanced Rectal 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 treatments for locally advanced rectal cancer. The study involves a combination of medications, including Durvalumab (also known as MEDI4736), Fluorouracil, Capecitabine, Calcium Folinate, and Oxaliplatin. Durvalumab is a type of medication that helps the immune system fight cancer by blocking a protein called PD-L1. The other medications are chemotherapy drugs that work by stopping the growth of cancer cells.

The purpose of this study is to evaluate the effectiveness of these treatments in achieving a complete response, meaning no signs of cancer remain after treatment. Participants will receive these medications as part of a treatment plan called Total Neoadjuvant Therapy (TNT), which is given before surgery to shrink the tumor. The study will involve regular visits to the clinic for treatment and monitoring, and participants will receive the medications either through an intravenous (IV) line or orally, depending on the specific drug.

Throughout the study, doctors will monitor the response to treatment using various methods, including imaging tests like MRI to assess changes in the tumor. The study aims to improve outcomes for patients with locally advanced rectal cancer by exploring the potential benefits of combining these medications. Participants will be followed up for a period to assess the long-term effects and any potential side effects of the treatment.

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 treatment phase

    The treatment begins with the administration of durvalumab through an intravenous route. This medication is given to help the immune system recognize and attack cancer cells.

    Alongside durvalumab, fluorouracil is administered intravenously. This is a type of chemotherapy that works by interfering with the growth of cancer cells.

  2. Step 2

    Oral medication phase

    During this phase, capecitabine is taken orally. Capecitabine is a chemotherapy drug that is absorbed through the digestive system and converted into fluorouracil in the body.

  3. Step 3

    Supportive treatment phase

    Calcium folinate is administered intravenously. This medication is used to enhance the effectiveness of fluorouracil and reduce its side effects.

  4. Step 4

    Additional chemotherapy phase

    Oxaliplatin is given intravenously. This is another chemotherapy drug that works by damaging the DNA of cancer cells, preventing them from dividing and growing.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular visits and examinations are scheduled to monitor the response to treatment and manage any side effects.

    The primary goal is to achieve a pathological complete response, meaning no cancer cells are found in tissue samples after treatment.

Who can join the trial?

12 criteria

  • The patient must provide written informed consent before any study-related procedures are done.
  • The patient must have normal functioning of their organs and bone marrow.
  • For women who can have children, they must either be post-menopausal or have a negative pregnancy test.
  • The patient must be willing and able to follow the study rules, including attending treatments, visits, and exams.
  • The patient must be at least 18 years old when joining the study.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must weigh more than 30 kilograms.
  • The patient must have a newly diagnosed rectal adenocarcinoma, which is a type of cancer in the rectum, confirmed by a biopsy. The tumor must be located less than 12 cm from the anal verge, which is the opening of the anus, as measured by a special scope.
  • The patient's rectal cancer must be **MSS (microsatellite stable)**, which is a specific characteristic of the cancer, confirmed by local testing methods.
  • The patient must agree to provide tumor and blood samples for additional research.
  • The patient must have high-risk rectal cancer as defined by an MRI scan.
  • The patient must not have any medical reasons that would prevent them from receiving chemotherapy and radiotherapy.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides locally advanced rectal cancer cannot participate. This means the cancer is in the rectum and has spread to nearby areas but not to distant parts of the body.
  • Patients who have had previous treatments for rectal cancer, such as surgery, chemotherapy, or radiation, are not eligible.
  • Patients with serious health conditions that could interfere with the study, such as severe heart or lung disease, cannot join.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who are unable to follow the study procedures or attend regular check-ups are excluded.
  • Patients with a history of another cancer within the last 5 years, except for certain skin cancers, are not eligible.
  • Patients who are currently participating in another clinical trial are not allowed to join this study.
  • Patients with known allergies to the study medications or their ingredients cannot participate.
  • Patients with active infections that require treatment are excluded.
  • Patients with a history of drug or alcohol abuse that could affect their ability to participate are not eligible.
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Investigated drugs

  • Durvalumab

    This medication is an immunotherapy drug used in the trial to help the body's immune system fight cancer cells. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Total Neoadjuvant Therapy (TNT)

    This is a combination of treatments given before the main treatment for cancer. In this trial, it involves using chemotherapy and radiation therapy to shrink the tumor and kill cancer cells in the rectal area before surgery. This approach aims to improve the chances of a successful surgery and reduce the risk of cancer returning.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating locally advanced rectal cancer. The main therapeutic indication for Durvalumab is to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. Durvalumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and attack cancer cells more effectively.

Investigated diseases

Locally advanced rectal cancer – This is a type of cancer that occurs in the rectum, which is the last part of the large intestine. It is considered "locally advanced" when the cancer has spread beyond the inner lining of the rectum but has not yet metastasized to distant organs. The disease typically progresses by invading nearby tissues and possibly spreading to nearby lymph nodes. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. As the cancer advances, it may cause more significant symptoms and complications. The progression of the disease can vary depending on various factors, including the size and location of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515240-24-00Protocol codeESR-17-13082Estimated enrolment60 patientsSponsorGrupo Espanol Multidisciplinar En Cancer Digestivo

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).