Study on Sonoporation-Enhanced Treatment with Gemcitabine, Nab-Paclitaxel, and FOLFIRINOX for Patients with Inoperable Pancreatic Cancer

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hyykx Bbtsbs Hs	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.12.2021

Trial locations

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.

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.

Trial ID:

2024-512176-35-00

NCT ID:

NCT04821284

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Sonoporation-Enhanced Treatment with Gemcitabine, Nab-Paclitaxel, and FOLFIRINOX for Patients with Inoperable Pancreatic Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?