Study of Durvalumab with Drug Combination for Patients with Locally Advanced Rectal Cancer

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What is this study about?

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.

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 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 supportive treatment phase

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

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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Cgtmpifm Smbteumq Inkvnevx	L'hospitalet De Llobregat	Spain
Phfu Twjmn Hzrlruwz Uotbgpezelbh	Sabadell	Spain
Hjgrqoiw Vpca dupjdfgi	Barcelona	Spain
Hnysnelb Uvavceefmlrrs do A Cyiklr	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	18.12.2019

Trial locations

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.

Investigated diseases:

Rectal cancer

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 ID:

2024-515240-24-00

Protocol code:

ESR-17-13082

NCT ID:

NCT04293419

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab with Drug Combination for Patients with Locally Advanced Rectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?