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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Universitair Ziekenhuis Gent Gent Belgium
CHU Saint Pierre Brussels Belgium
Grand Hopital De Charleroi Charleroi Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Chirec Brussels Belgium
CHU Helora La Louviere Belgium
Ctittmuik Upxcobkhpgcisu Slncbubit Woluwe-Saint-Lambert Belgium
Cudftp Hfpfnkiomiw Rlegwdnw Stintg es Mcngv Namur Belgium
Unyeoypcxp Or Aiejflf Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.01.2021

Trial locations

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.

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 ID:
2024-516554-22-00
Protocol code:
IJB-REGINA-2020
Trial Phase:
Therapeutic exploratory (Phase II)

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