Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on Organ Preservation in Advanced Rectal Cancer Patients Using Bleomycin and Electrochemotherapy After Initial Treatment

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 type of cancer known as colorectal cancer, specifically targeting cases where the cancer is located in the rectum. The study is exploring a treatment approach that combines initial therapy, known as neoadjuvant treatment, with a procedure called electrochemotherapy. Electrochemotherapy involves using electrical pulses to help a drug, in this case, bleomycin, work more effectively against cancer cells.

The purpose of the study is to evaluate whether this combined treatment can safely and effectively increase the rate of complete response, meaning the cancer is no longer detectable, while also aiming to preserve the affected organ. Participants in the study will first receive the neoadjuvant treatment to shrink the tumor, followed by the electrochemotherapy procedure. The study will monitor the safety and feasibility of this approach and assess the response of the cancer to the treatment.

Throughout the study, participants will undergo various assessments to ensure their safety and to evaluate the effectiveness of the treatment. The ultimate goal is to determine if this method can improve outcomes for patients with locally advanced rectal cancer, potentially offering a way to treat the cancer while preserving the function of the rectum.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including age, diagnosis, and treatment history.

    Eligibility requires a confirmed diagnosis of rectal adenocarcinoma and a significant response to prior treatment.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current status of the rectal tumor.

    This assessment includes a review of medical history and physical examination.

  3. Step 3

    Neoadjuvant treatment

    Patients undergo neoadjuvant treatment, which is therapy given before the main treatment to shrink the tumor.

    The goal is to achieve a major clinical response, making the tumor more manageable.

  4. Step 4

    Electrochemotherapy

    Following neoadjuvant treatment, electrochemotherapy is administered.

    This involves the use of bleomycin, a medication given through intravenous use.

    The procedure aims to enhance the response rate and facilitate organ sparing.

  5. Step 5

    Evaluation of response

    The response to treatment is evaluated through histopathological analysis.

    This involves examining tissue samples to assess the extent of tumor response.

  6. Step 6

    Follow-up

    Regular follow-up appointments are scheduled to monitor health and treatment outcomes.

    These appointments help ensure the safety and effectiveness of the treatment.

Who can join the trial?

7 criteria

  • Male or female patients aged 18 years or older.
  • Must have a histological confirmation of rectal adenocarcinoma, which means a tissue sample has been examined under a microscope to confirm the type of cancer.
  • Patients should be undergoing neoadjuvant treatment for a locally advanced tumor of the rectum. This is treatment given before the main treatment to shrink the tumor.
  • Must have a confirmed major clinical response after neoadjuvant treatment, meaning the tumor has responded well to the initial treatment.
  • The rectal tumor should be located up to 12 cm from the external anal margin.
  • Patients must be willing to follow the study protocol and provide their informed written consent, which means they agree to participate after understanding the study details.
  • Patients should have an ECOG status performance of less than 3. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with lower numbers indicating better functioning.

Who cannot join the trial?

4 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.
  • Individuals who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population are not included. A vulnerable population might include people who are unable to give informed consent or who are at a higher risk of harm.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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 therapy is being studied for its potential to treat locally advanced rectal cancer by increasing the complete response rate, which means reducing or eliminating the cancer without needing to remove the organ.

What is already known about the treatment

Electrochemotherapy – This treatment is administered through a combination of electrical pulses and chemotherapy drugs, typically applied directly to the tumor site. It is currently being explored in clinical trials for its effectiveness in treating locally advanced rectal cancer, with a focus on organ preservation. The main therapeutic indication is colorectal cancer, specifically targeting tumors that have not responded fully to initial treatments. The mechanism of action involves enhancing the uptake of chemotherapy drugs into cancer cells by temporarily increasing cell membrane permeability through electrical pulses. Electrochemotherapy is classified under cancer treatment modalities that combine physical and chemical methods to improve therapeutic outcomes.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that starts in the colon or rectum, which are parts of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The progression of the disease can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. As the cancer advances, it may spread to other parts of the body. Early detection and removal of polyps can prevent the development of colorectal cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519050-37-00Estimated enrolment70 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.