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Study on the Effectiveness of Laparoscopic Electrochemotherapy with Bleomycin Sulfate for Patients with Locally Advanced Pancreatic Cancer

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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 the treatment of Locally Advanced Pancreatic Cancer. The study will explore the effectiveness of a method called electrochemotherapy, which is a treatment that combines electrical pulses with chemotherapy drugs to target cancer cells. The chemotherapy drugs used in this study include Bleomycin, Fluorouracil, Calcium Levofolinate, Irinotecan, and Oxaliplatin. These drugs are commonly used in cancer treatment and will be administered through injections or infusions.

The purpose of the study is to evaluate how well electrochemotherapy works when followed by standard chemotherapy, compared to using only standard chemotherapy. The study will use a minimally invasive surgical technique called laparoscopy, which involves small incisions and is less risky than traditional open surgery. This approach aims to make the treatment more accessible and safer for patients.

Participants in the study will receive either the combination of electrochemotherapy and standard chemotherapy or just the standard chemotherapy. The study will monitor the response of the cancer to the treatments, as well as the impact on the patient's quality of life, including pain levels. The study will also assess the safety of electrochemotherapy and its potential to make the cancer operable. The trial is expected to continue until 2030, with recruitment starting in 2024.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, mental health, and diagnosis of locally advanced pancreatic cancer.
Consent is required to participate, ensuring understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status and stage of the cancer.
This assessment helps in planning the treatment approach and monitoring progress throughout the study.
Step 3
Electrochemotherapy procedure
The study involves a procedure called electrochemotherapy, which uses electrical pulses to enhance the effect of chemotherapy drugs on cancer cells.
This procedure is performed using a minimally invasive technique called laparoscopic surgery, which involves small incisions and the use of special instruments.
Step 4
Systemic treatment
Following the electrochemotherapy, a conventional systemic treatment is administered. This includes a combination of drugs: bleomycin sulfate, fluorouracil, calcium levofolinate, irinotecan hydrochloride trihydrate, and oxaliplatin.
These medications are given through an intravenous route, meaning they are delivered directly into the bloodstream through a vein.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects experienced.
Follow-up appointments are scheduled to evaluate the progression of the disease and the overall health status.
Step 6
Completion of the study
Upon completion of the study, a final assessment is conducted to determine the effectiveness of the treatment.
Participants are provided with information on the outcomes and any further steps that may be necessary for their care.

Who can join the trial?

7 criteria

Must be at least 18 years old.
Must have good mental health.
Must be able to sign a specific informed consent to join the study. This means you understand the study and agree to participate.
Must have a life expectancy that matches the follow-up period of the study. This means your health condition should allow you to complete the study.
Must have a diagnosis of exocrine pancreatic cancer confirmed by a tissue sample test.
Must have locally advanced pancreatic cancer at stage III, which means the cancer has spread to nearby areas but not to distant parts of the body.
Must not be eligible for the standard surgery to remove the pancreas but should be eligible for a conventional systemic treatment called FOLFOXIRI, which is a type of chemotherapy.

Who cannot join the trial?

10 criteria

Patients who have had a recent major surgery or are planning to have one soon.
Patients with other serious illnesses that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medications or treatments.
Patients who are unable to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently.
Patients with a history of certain heart conditions.
Patients with uncontrolled infections.
Patients with a history of drug or alcohol abuse.
Patients who are not able to give informed consent.

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Verified sites

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

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A.O.U. Policlinico G. Martino Di Messina
Messina, Italy
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Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
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Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy

Trial locations

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Investigated drugs

Electrochemotherapy (ECT)
is a treatment that combines chemotherapy with electrical pulses to enhance the effectiveness of the drug. In this trial, ECT is used to treat locally advanced pancreatic cancer. The electrical pulses help the chemotherapy drug enter the cancer cells more easily, which can make the treatment more effective. This approach is being tested using a minimally invasive surgery called laparoscopy, which involves small incisions and is less risky than traditional open surgery.
Conventional Systemic Treatment
refers to the standard chemotherapy drugs that are commonly used to treat pancreatic cancer. These drugs are given through the bloodstream and work throughout the entire body to target and kill cancer cells. In this trial, the systemic treatment is used after the electrochemotherapy to see if the combination is more effective than using the systemic treatment alone.

What is already known about the treatment

Electrochemotherapy – Electrochemotherapy is a treatment method that combines chemotherapy with electrical pulses to enhance the effectiveness of the drug. It is administered through a minimally invasive procedure called laparoscopic surgery, which involves small incisions and the use of electrodes to deliver the treatment directly to the tumor. Currently, this method is being studied for its effectiveness in treating locally advanced pancreatic cancer. The main therapeutic indication is to improve the response of tumors that are difficult to treat with conventional methods. At the molecular level, the electrical pulses increase the permeability of cancer cell membranes, allowing the chemotherapy drug to enter the cells more effectively. This treatment is classified under cancer therapies that utilize physical methods to enhance drug delivery.

Investigated diseases

Locally Advanced Pancreatic Cancer – This is a stage of pancreatic cancer where the tumor has grown beyond the pancreas but has not spread to distant organs. It often involves nearby blood vessels, making surgical removal challenging. The disease progresses as the tumor continues to grow and may invade surrounding tissues and organs. Symptoms can include abdominal pain, weight loss, and jaundice. As the cancer advances, it can lead to complications such as digestive issues and diabetes. The progression of the disease can vary, with some cases remaining stable for a period before further advancement.