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Study on the Effects of Calcium Chloride and Bleomycin with Electroporation Techniques for Patients with Unresectable Pancreatic 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 the effects of three different treatments on patients with pancreatic cancer that cannot be surgically removed. The treatments being tested are calcium electroporation, electrochemotherapy, and irreversible electroporation. Calcium electroporation involves using a solution called calcium chloride dihydrate, while electrochemotherapy uses a medication called bleomycin. The purpose of the study is to evaluate how these treatments affect the quality of life and the time patients live without the disease getting worse.

During the study, participants will receive one of the treatments, and their health will be monitored over time. The study will look at how long patients live without the cancer progressing, as well as their overall survival, changes in body weight, pain levels, and quality of life. The study will also explore changes in certain blood markers and other health indicators. The treatments are given through injections, and the study aims to understand the safety and effectiveness of these methods in managing pancreatic cancer.

Participants will be followed up regularly to assess their health and any changes in their condition. The study will continue until 2027, and it aims to provide valuable information on new ways to treat pancreatic cancer, potentially improving the lives of those affected by this challenging disease.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Imaging tests such as CT or MRI scans are performed to assess the size and location of the pancreatic tumor.
Step 2
Treatment planning
A treatment plan is developed based on the initial assessment. This plan includes the use of calcium electroporation, electrochemotherapy, and irreversible electroporation (IRE).
The specific approach is tailored to the individual's condition and tumor characteristics.
Step 3
Treatment administration
The treatment involves the administration of calcium chloride dihydrate and bleomycin through intratumoral injection.
Calcium chloride dihydrate is provided as a solution for injection at a concentration of 67 mg/ml.
Bleomycin is administered as a powder to prepare a solution for injection, with a dosage of 15,000 IU per vial.
The treatment is delivered directly into the tumor using specialized techniques to enhance the effectiveness of the drugs.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the patient's response to treatment and overall health.
Progression-free survival is assessed, which is the time from the start of treatment until the disease progresses or the patient passes away.
Additional assessments include overall survival, changes in body weight, pain levels, and quality of life evaluations using specific questionnaires.
Step 5
End of study
The study is estimated to conclude by June 30, 2027.
Final evaluations are conducted to gather data on the long-term effects of the treatment and its impact on quality of life and survival.

Who can join the trial?

7 criteria

Must be over 18 years old, both men and women can participate.
Must provide written informed consent, which means agreeing to participate after understanding the study details.
Must have a confirmed diagnosis of a type of pancreatic cancer called adenocarcinoma. This can be confirmed during surgery if needed.
The cancer must be considered unresectable, meaning it cannot be removed by surgery. This is determined if the cancer affects certain blood vessels in the abdomen, as seen on a CT or MRI scan done within the last 60 days. It can also include patients who had surgery but the cancer has come back locally.
The tumor must not be larger than 6 cm, as shown on a CT or MRI scan done within the last 60 days.
Can include patients who are currently receiving chemotherapy or those newly diagnosed with pancreatic cancer.
Must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations but still able to care for oneself.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides pancreatic cancer cannot participate.
Patients who have had surgery to remove their pancreatic cancer are not eligible.
Patients who are unable to undergo the specific treatments being studied, such as irreversible electroporation (IRE), calcium electroporation, or electrochemotherapy (ECT), cannot join. These are special treatments that use electricity and chemicals to target cancer cells.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need extra protection or care, may not be eligible.
Patients who have any medical conditions or take medications that could interfere with the study treatments are not eligible.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible.

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Verified sites

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Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
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Wroclaw, Poland

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Investigated drugs

Calcium Electroporation
is a treatment that involves using electrical pulses to introduce calcium into cancer cells. This method aims to kill cancer cells by disrupting their internal balance, potentially improving the quality of life and survival of patients with pancreatic cancer.
Electrochemotherapy (ECT)
combines chemotherapy with electrical pulses to enhance the effectiveness of the chemotherapy drugs. The electrical pulses help the drugs enter the cancer cells more efficiently, which may lead to better treatment outcomes for patients with pancreatic cancer.
Irreversible Electroporation (IRE)
is a technique that uses electrical pulses to create tiny holes in the cell membranes of cancer cells. This process can lead to cell death and is used to target and destroy cancerous tissue in patients with pancreatic cancer.

What is already known about the treatment

Calcium Chloride – This medication is administered through electroporation, a method that uses electrical pulses to enhance the delivery of calcium ions directly into cancer cells. It is currently being studied in clinical trials for its potential to improve quality of life and progression-free survival in patients with unresectable pancreatic cancer. The main therapeutic indication is for pancreatic cancer that cannot be surgically removed. At the molecular level, calcium chloride works by disrupting the balance of calcium ions within cancer cells, leading to cell death. It is classified under the category of experimental cancer treatments.

Investigated diseases

Unresectable Pancreatic Cancer – This is a type of pancreatic cancer that cannot be removed through surgery due to its location or extent of spread. It typically begins in the tissues of the pancreas, an organ that lies behind the lower part of the stomach. As the disease progresses, it may invade nearby organs or spread to distant parts of the body. Symptoms often include abdominal pain, weight loss, and jaundice. The progression of the disease can lead to complications such as digestive issues and diabetes. Management focuses on controlling symptoms and slowing the progression of the disease.