Not recruiting

Study on Sonoporation-Enhanced Treatment with Gemcitabine, Nab-Paclitaxel, and FOLFIRINOX for Patients with Inoperable 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 pancreatic cancer, specifically in patients whose cancer cannot be surgically removed. The study is exploring the use of a treatment method called sonoporation-enhanced treatment, which involves using sound waves to help deliver medications more effectively. The medications being studied include Gemcitabine, Nab-Paclitaxel, and a combination treatment known as FOLFIRINOX. Additionally, a substance called Sonazoid is used under ultrasound guidance to enhance the treatment. The purpose of the study is to evaluate the safety and effectiveness of these combined treatments compared to using Gemcitabine, Nab-Paclitaxel, or FOLFIRINOX alone.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over a period of time, with regular monitoring to assess how the cancer responds to the treatment. The study aims to understand if the combination of these treatments can improve outcomes for patients with inoperable pancreatic cancer.

Throughout the study, researchers will track various outcomes, such as how long patients live without the cancer getting worse and overall survival rates. The study will also look at how many chemotherapy cycles patients can complete before the treatment is no longer effective. This research is important for finding new ways to treat pancreatic cancer and potentially improve the quality of life for those affected by this 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 verifying a new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma and ensuring the ability to perform daily activities with an ECOG performance status between 0 and 2.
Female participants of child-bearing potential must have a negative pregnancy test and agree to use effective birth control. Male participants with partners of child-bearing potential must agree to use a condom during the study and for six months after the last treatment.
Step 2
Treatment initiation
The treatment involves the administration of Gemcitabine and Nab-Paclitaxel or FOLFIRINOX combined with Sonazoid under ultrasound guidance. The goal is to evaluate the safety and effectiveness of this combination compared to the chemotherapy alone.
The medications are administered through intravenous infusion. The specific dosages and frequency are determined by the study protocol and the healthcare team.
Step 3
Ongoing treatment and monitoring
Participants receive regular treatments as per the study schedule. The healthcare team monitors the response to treatment and any side effects.
Progression-free survival is assessed using RECIST criteria, which involves imaging tests to measure tumor size and progression.
Step 4
Evaluation of treatment outcomes
The primary outcome is progression-free survival. Secondary outcomes include overall survival, time to treatment failure, and changes in tumor size and disease progression.
These outcomes are measured using imaging techniques such as CT and ultrasound.
Step 5
Completion of study participation
The study is estimated to conclude by December 31, 2026. Participants will continue to be monitored for any long-term effects and overall survival.
The number of completed chemotherapy cycles before treatment failure is also recorded.

Who can join the trial?

6 criteria

Must have a new diagnosis of **metastatic** or **locally advanced pancreatic ductal adenocarcinoma**. This means the cancer has spread to other parts of the body or is advanced in the pancreas.
Must be able to walk and perform daily activities with an **ECOG performance status** between 0 and 2. This is a scale that measures how well a person can carry out daily activities, with 0 being fully active and 2 being able to walk and manage self-care but unable to work.
Female patients who can have children must have a negative urine pregnancy test and agree to use an effective birth control method during the study.
Male patients with a female partner who can have children must agree to use a condom during the study and for 6 months after the last treatment.
Must sign an informed consent form, which means agreeing to participate in the study and understanding what it involves, following international and local regulations.
Must be **18 years old** or older.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with pancreatic cancer cannot participate.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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Helse Bergen HF
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Bergen, Norway

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Investigated drugs

Gemcitabine
is a medication used in the treatment of various types of cancer, including pancreatic cancer. It works by slowing or stopping the growth of cancer cells.
Nab-Paclitaxel
is a form of chemotherapy that uses tiny particles to deliver the drug paclitaxel to cancer cells. It is used to treat pancreatic cancer by interfering with the growth of cancer cells.
FOLFIRINOX
is a combination of several chemotherapy drugs used to treat pancreatic cancer. It includes a mix of drugs that work together to stop cancer cells from dividing and growing.
Sonazoid
is a contrast agent used in ultrasound imaging. In this trial, it is used to enhance the delivery of chemotherapy drugs to the cancer cells through a process called sonoporation, which uses ultrasound waves to temporarily open cell membranes.

What is already known about the treatment

Gemcitabine
This medication is administered intravenously and is used in the treatment of pancreatic cancer. It is well-established in medical literature as a chemotherapy agent. Gemcitabine works by interfering with DNA synthesis, thereby preventing cancer cells from growing and dividing. It belongs to the pharmacological class of antimetabolites.
Nab-Paclitaxel
Administered intravenously, Nab-Paclitaxel is used for treating pancreatic cancer. It is recognized in medical literature as a chemotherapy drug. The medication works by stabilizing microtubules, which inhibits cell division and leads to cancer cell death. It is classified as a taxane.
FOLFIRINOX
This combination chemotherapy regimen is administered intravenously and is used for pancreatic cancer treatment. It is well-documented in medical literature. FOLFIRINOX includes a mix of drugs that work together to inhibit DNA replication and cell division, effectively targeting cancer cells. It is classified under combination chemotherapy regimens.
Sonazoid
Administered via ultrasound-enhanced delivery, Sonazoid is being investigated for its potential to improve the effectiveness of chemotherapy in pancreatic cancer. It is currently under clinical evaluation. Sonazoid works by enhancing the delivery of chemotherapy drugs to cancer cells through sonoporation, a process that temporarily opens cell membranes. It is classified as a contrast agent used in ultrasound imaging.

Investigated diseases

Pancreatic cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar regulation. It often begins in the cells that produce digestive juices or hormones. As the cancer progresses, it can invade nearby organs and spread to other parts of the body. Symptoms may include jaundice, weight loss, and abdominal pain, but these often appear only in advanced stages. The disease can grow and spread quickly, making early detection challenging. It is typically diagnosed at a later stage due to its subtle early symptoms.