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Study on Electrochemotherapy with Bleomycin for Patients with Colorectal Cancer

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 clinical trial is focused on studying a treatment for colorectal cancer, which is a type of cancer that affects the colon or rectum. The treatment being tested is called electrochemotherapy, which combines the use of electrical pulses with a cancer-fighting drug called bleomycin. The study aims to find out if this combination is more effective in reducing the size of tumors before surgery compared to using electrical pulses alone.

Participants in the study will receive either the electrochemotherapy treatment or a treatment with electrical pulses and a placebo, which in this case is a harmless solution called saline. The study will monitor the effects of these treatments on the tumor and any side effects that may occur. The goal is to see if the new treatment can help make the tumors smaller and easier to remove during surgery.

The study will also look at changes in the tumor environment, such as the presence of immune cells and other factors that might affect how the tumor grows. This research is important for understanding how to improve treatment options for people with colorectal cancer and to potentially increase the chances of successful surgery. The study is expected to continue until 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment
The treatment begins with the administration of bleomycin and saline. These are given as a solution for injection or infusion directly into the vein, a method known as intravenous administration.
The purpose of this step is to prepare the body for the main treatment phase, which involves electrochemotherapy.
Step 2
Electrochemotherapy
Electrochemotherapy is used to enhance the effects of the medication. This involves applying electrical pulses to the tumor area, which helps the medication penetrate cancer cells more effectively.
This step is crucial for reducing the size of the tumor before surgery.
Step 3
Monitoring for adverse events
After the treatment, there is a period of monitoring to evaluate any serious or minor adverse events. This monitoring continues until the surgery and for 30 days after the treatment.
The focus is on ensuring patient safety and managing any side effects that may occur.
Step 4
Surgery preparation
Following the treatment and monitoring phase, preparations for surgery begin. The goal is to remove the tumor with a standard surgical procedure.
This step involves consultations with the medical team to ensure the patient is ready for surgery.
Step 5
Surgery
The final step is the surgical removal of the tumor. This is intended to be a curative procedure, aiming to eliminate the cancerous tissue.
The surgery is planned based on the results of the previous treatment phases and the patient's overall health status.

Who can join the trial?

7 criteria

Patients must be mentally capable of understanding the information given.
Patients must give written informed consent, which means they agree to participate after being informed about the study.
Patients must have a tumor in the rectum or sigmoid colon that is either suspected through an endoscopy or confirmed by a biopsy. An endoscopy is a procedure where a doctor uses a camera to look inside the body, and a biopsy is when a small piece of tissue is taken to check for cancer.
The tumor must be described as passable at the initial endoscopy, meaning it can be accessed or reached during the procedure.
Participants can be men or women who are at least 18 years old.
The patient's case must be reviewed by a team of doctors from different specialties, including surgery, radiology, and oncology, and considered curable with standard surgical removal of the tumor.
Patients must be classified as ASA class I-II. This is a system used by the American Society of Anesthesiology to assess the physical health of patients before surgery. Class I means a healthy patient, and class II means a patient with mild systemic disease.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with colorectal cancer cannot participate. Colorectal cancer is a type of cancer that affects the colon or rectum, which are parts of the large intestine.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may have a higher risk of harm or exploitation.

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Region Sjaelland
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Holbæk, Denmark

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Investigated drugs

Electrochemotherapy
is a treatment that combines chemotherapy with electrical pulses. The electrical pulses help the chemotherapy drugs enter cancer cells more effectively. This method is being tested to see if it can shrink tumors in patients with colorectal cancer before surgery.
Electroporation
is a technique that uses electrical pulses to create temporary openings in cell membranes. This allows substances, like chemotherapy drugs, to enter the cells more easily. In this trial, electroporation is used alone to see how effective it is in shrinking tumors before surgery.

Bleomycin

What is already known about the treatment

Electrochemotherapy – This treatment is administered through a combination of chemotherapy drugs and electrical pulses directly to the tumor site. It is currently being studied in clinical trials for its effectiveness in treating colorectal cancer. The main therapeutic indication is to reduce tumor size before surgery. The mechanism of action involves enhancing the uptake of chemotherapy drugs into cancer cells by temporarily increasing cell membrane permeability through electrical pulses. It is classified under cancer treatment modalities that combine physical and chemical methods.

Investigated diseases

Colorectal cancer – This disease involves the development of cancerous cells in the colon or rectum, which are parts of the large intestine. It typically begins as small, noncancerous clumps of cells called polyps that form on the inner lining of the colon or rectum. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may spread to distant organs.