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Study of Regorafenib and Nivolumab with radiotherapy for patients with stage II-III rectal cancer before surgery

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 study focuses on patients with stage II-III rectal cancer that is locally advanced. The treatment combines three different approaches: two medications - nivolumab and regorafenib - along with short-course radiotherapy. Both medications are given to patients before and after the radiotherapy treatment.

Nivolumab is administered through an intravenous infusion (through a vein), while regorafenib is taken as tablets by mouth. The study aims to determine if this combination of treatments can achieve a complete response in patients whose tumors have specific characteristics (referred to as pMMR/MSS tumors). A complete response means that there are no signs of cancer remaining after the treatment.

During the study, patients receive nivolumab infusions at a maximum daily dose of 240 mg, with a total maximum dose of 1200 mg over 5 weeks. Regorafenib tablets are given at a maximum daily dose of 60 mg, with a total maximum dose of 2040 mg over 34 weeks. Patients undergo regular medical examinations and imaging tests throughout the treatment period to monitor their response to the therapy.

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

    You will receive two medications: nivolumab through an intravenous infusion and regorafenib tablets for oral use

    These medications will be administered before the standard radiotherapy treatment

  2. Step 2

    Radiotherapy treatment

    You will undergo short-course radiotherapy (SCRT), which is a standard pre-operative treatment

    The radiotherapy will be focused on the rectal area affected by cancer

  3. Step 3

    Post-radiotherapy treatment

    After radiotherapy, you will continue receiving nivolumab and regorafenib

    Regular monitoring of your blood counts, liver function, and kidney function will be performed to ensure safety

  4. Step 4

    Response evaluation

    Your response to the treatment will be evaluated through medical examinations

    The doctors will assess if there has been a complete response to the treatment, meaning no detectable cancer remains

  5. Step 5

    Follow-up period

    Regular follow-up visits will be scheduled to monitor your health status

    Medical imaging tests will be performed to check for any signs of cancer recurrence

    The total follow-up period will continue until January 2030

Who can join the trial?

18 criteria

  • Must be at least 18 years old
  • Can be either female or male
  • Must have confirmed rectal cancer (adenocarcinoma) through tissue examination
  • The tumor must be located within 15 cm from the anal opening and below the peritoneal fold
  • Must have good overall physical condition (ECOG score 0-1, meaning able to perform daily activities)
  • Life expectancy must be at least 3 months
  • Must have adequate kidney function
  • Must have adequate liver function
  • Must have adequate blood cell counts, including:
    • Sufficient white blood cells
    • Sufficient platelets
    • Sufficient hemoglobin (oxygen-carrying protein)
    • Women who can become pregnant must have a negative pregnancy test
    • Women who can become pregnant must use effective birth control during the study and for 7 months after
    • Men with partners who can become pregnant must use condoms during the study and for 5 months after
    • Must complete all screening tests within 28 days before joining the study
    • Must sign an informed consent form before any study procedures
    • Must be able to comply with study requirements and follow-up visits
    • Must not have any conditions that would prevent treatment or surgery

Who cannot join the trial?

13 criteria

  • Prior treatment with any cancer therapy for rectal cancer including chemotherapy, targeted therapy, immunotherapy, or radiation therapy
  • Active or untreated brain or central nervous system metastases (spread of cancer to brain)
  • Known autoimmune disease (condition where immune system attacks healthy cells)
  • Active, known, or suspected infection requiring systemic treatment
  • History of organ transplant requiring immunosuppressive medications
  • Use of systemic corticosteroids or other immunosuppressive medications within 14 days before starting study treatment
  • Uncontrolled high blood pressure or significant heart disease
  • Major surgery within 28 days before starting study treatment
  • Active bleeding or high risk of bleeding complications
  • Pregnant or breastfeeding women
  • Known allergy or sensitivity to study medications
  • Any condition that would make the patient unable to comply with study procedures
  • Participation in another clinical trial within 28 days before starting this study
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Investigated drugs

Regorafenib is a medication used to treat cancer. It belongs to a group of drugs called kinase inhibitors, which work by blocking certain proteins that help cancer cells grow and spread. In this trial, it is being studied as a treatment for rectal cancer. Nivolumab is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune system cells) from attacking cancer cells. By blocking PD-1, nivolumab helps the immune system recognize and destroy cancer cells. Short-course radiotherapy (SCRT) is a type of radiation therapy that delivers targeted radiation to kill cancer cells over a shorter period than traditional radiotherapy. It is a standard treatment approach used before surgery in rectal cancer patients to help shrink the tumor and make it easier to remove during surgery.

What is already known about the treatment

  • Regorafenib

    An oral multi-kinase inhibitor medication taken in tablet form that blocks several protein kinases involved in tumor growth and blood vessel development. It is currently approved for treating colorectal cancer and is being investigated in clinical trials for locally advanced rectal cancer in combination with other treatments. This medication works by targeting multiple cellular pathways that help cancer cells grow and spread, including those involved in angiogenesis and tumor microenvironment modification.

  • Nivolumab

    An intravenously administered immunotherapy medication belonging to the class of PD-1 inhibitors that helps the immune system fight cancer cells. It is widely used in various cancer treatments and is being studied in combination with other therapies for rectal cancer treatment. The medication works by blocking the PD-1 protein on immune cells, which enables the body's T-cells to better recognize and attack cancer cells, effectively boosting the natural immune response against tumors.

Investigated diseases

Rectal Cancer - A type of cancer that begins in the rectum, which is the last several inches of the large intestine. The disease typically develops from small growths called polyps that form on the inner wall of the rectum. Over time, these polyps can become cancerous and grow into the deeper layers of the rectal wall. In stage II-III (locally advanced), the cancer has grown through the wall of the rectum and may spread to nearby tissues or lymph nodes, but has not spread to distant parts of the body. The condition often develops slowly, and early stages may not cause noticeable symptoms. The disease is part of a larger group of colorectal cancers, which affect the lower digestive system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516554-22-00Protocol codeIJB-REGINA-2020Estimated enrolment90 patientsSponsorInstitut Jules Bordet

sourced from the EU Clinical Trials Register and site verification

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