Recruiting

Study Comparing Gemcitabine and Paclitaxel Albumin-Bound for Fragile Patients with Non-Resectable Pancreatic Cancer

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 treatments for pancreatic cancer, a type of cancer that begins in the tissues of the pancreas. The study is comparing two different treatments for patients whose cancer cannot be removed by surgery. The first treatment involves the use of Gemcitabine, a medication that is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The second treatment is a combination of Gemcitabine and Abraxane (also known as paclitaxel albumin-bound), which is also given through an intravenous infusion but at a reduced dose.

The purpose of this study is to determine which treatment is more effective for patients who are not able to undergo full-dose combination chemotherapy. Participants in the study will be randomly assigned to receive either the standard dose of Gemcitabine or the reduced-dose combination of Gemcitabine and Abraxane. The study will monitor the participants over a period of time to see how the treatments affect their cancer and overall health. The main focus will be on how long the patients live without their cancer getting worse, known as progression-free survival. Other aspects such as overall survival, response to treatment, number of hospitalizations, and quality of life will also be assessed.

This study is designed for patients who are considered fragile or not suitable for full-dose chemotherapy. It aims to provide insights into the best treatment options for these patients, helping to improve their quality of life and manage their condition more effectively. The study will continue until December 2026, with the goal of gathering comprehensive data on the effectiveness and safety of these treatment options.

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
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide oral and written consent to participate.
Eligibility criteria include being 18 years or older, having a confirmed diagnosis of non-resectable pancreatic cancer, and meeting specific health requirements.
Step 2
Treatment assignment
The patient will be randomly assigned to one of two treatment groups: standard dose gemcitabine or reduced-dose combination chemotherapy with gemcitabine and paclitaxel albumin-bound (also known as Abraxane).
Step 3
Treatment administration
The medications will be administered intravenously, meaning they will be given through a vein.
The standard dose group will receive gemcitabine as a solution for infusion.
The reduced-dose combination group will receive both gemcitabine and paclitaxel albumin-bound as a dispersion for infusion.
Step 4
Monitoring and assessments
Throughout the trial, the patient's health and response to treatment will be closely monitored.
Assessments will include measuring progression-free survival, overall survival, response rate, and quality of life.
Quality of life will be evaluated using a questionnaire at the start and after 8, 16, and 24 weeks.
Step 5
Completion of the trial
The trial is expected to continue until December 2026.
Upon completion, the patient's overall health and treatment outcomes will be reviewed.

Who can join the trial?

12 criteria

Must be at least 18 years old.
Any side effects from previous chemotherapy, like nerve damage, should be mild or gone.
Must agree to participate by signing a consent form, both orally and in writing, as required by local rules.
If able to have children, must use effective birth control methods.
Must have a type of pancreatic cancer called adenocarcinoma, confirmed by tests.
Cancer must be non-resectable, meaning it cannot be removed by surgery. This includes cancer that has spread locally or to other parts of the body.
Not suitable for full-dose combination chemotherapy.
Eligible for full-dose gemcitabine or a reduced dose of combination chemotherapy.
Must have a performance status of 2 or less, which means being able to do daily activities with some help.
Must have cancer that can be measured or not measured by tests.
Must have enough healthy blood cells, with specific counts for white blood cells and platelets, checked within two weeks before joining the study.
Must have organs working well enough, with specific levels for bilirubin (a liver function test) and kidney function, checked within two weeks before joining the study.

Who cannot join the trial?

9 criteria

Patients who have had a different type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
Patients who have serious heart problems, such as heart failure or a recent heart attack.
Patients with severe liver disease, which means the liver is not working well.
Patients with severe kidney disease, which means the kidneys are not working well.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that needs treatment.
Patients who have a known allergy to the study drugs.
Patients who are participating in another clinical trial at the same time.
Patients who have a condition that the study doctors think would make it unsafe for them to 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.

We usually reply within a few days

Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Herlev Hospital
Verified
Herlev, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

Trial locations

Where you can join this trial

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

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

Gemcitabine
is a medication used in this study to treat patients with non-resectable pancreatic cancer. It is a type of chemotherapy that works by slowing or stopping the growth of cancer cells. In this trial, it is being used to see if it is effective for patients who cannot undergo surgery or are not suitable for full-dose combination chemotherapy.
GemNab
is a combination therapy used in this study, which includes gemcitabine and another drug. This combination is given at a reduced dose to see if it is a better treatment option for patients with non-resectable pancreatic cancer who are considered fragile or not fit for the standard full-dose chemotherapy. The goal is to determine if this reduced-dose combination is more effective or better tolerated by these patients.

What is already known about the treatment

Gemcitabine – This medication is administered intravenously, meaning it is given through a vein. It is currently used in the treatment of various cancers, including pancreatic cancer, and is well-documented in medical literature. The main therapeutic indication for gemcitabine is pancreatic cancer, especially in patients who cannot undergo surgery. At the molecular level, gemcitabine works by interfering with DNA synthesis, which prevents cancer cells from growing and dividing. It is classified as an antimetabolite, a type of chemotherapy drug that targets rapidly dividing cells.

Investigated diseases

Pancreatic cancer – This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As the disease advances, it may cause abdominal pain, weight loss, jaundice, and digestive problems. The cancer can spread to nearby organs and lymph nodes, complicating its progression. It is known for its aggressive nature and tendency to metastasize early. The progression of pancreatic cancer can vary, but it typically involves the growth of malignant cells that disrupt normal pancreatic function.