Study on FOLFIRINOX, Pembrolizumab, and SABR for Patients with Borderline Resectable Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying treatments for pancreatic cancer, specifically a type known as borderline resectable pancreatic cancer (BRPC). The study will use a combination of treatments, including a chemotherapy regimen called FOLFIRINOX, the immunotherapy drug pembrolizumab (also known as KEYTRUDA), and a type of radiation therapy called stereotactic ablative body radiotherapy (SABR). The purpose of the study is to investigate whether this combination of treatments, followed by surgery and additional chemotherapy and immunotherapy, can improve the time patients live without the cancer getting worse.

Participants in the study will first receive the combination of FOLFIRINOX, pembrolizumab, and SABR. After this initial treatment, patients will undergo surgery to remove the cancer if possible. Following surgery, patients will receive more FOLFIRINOX and pembrolizumab to help prevent the cancer from returning. The study aims to see if this approach can help patients live longer without the cancer progressing.

The study will also look at other important outcomes, such as overall survival, the success rate of surgeries, and the side effects of the treatments. Additionally, it will assess the quality of life of participants and how well they respond to the treatments. This trial is part of ongoing research to find better ways to treat pancreatic cancer and improve outcomes for patients with this challenging disease.

1 initial treatment phase

The initial treatment phase involves a combination of medications administered through infusions. These medications include oxaliplatin, pembrolizumab, folinic acid, fluorouracil, and irinotecan hydrochloride trihydrate.

Each medication is given as an infusion, which means it is delivered directly into the bloodstream through a vein. The specific schedule and dosage will be determined by the healthcare team based on individual needs and responses.

2 radiotherapy

Following the initial treatment phase, stereotactic ablative body radiotherapy (SABR) is administered. This is a type of radiation therapy that targets the tumor with high precision.

The goal of SABR is to shrink the tumor and make it easier to remove surgically.

3 surgical resection

After completing the radiotherapy, the next step is surgical resection. This involves the surgical removal of the tumor.

The timing and specifics of the surgery will depend on the response to the previous treatments and the overall health status.

4 adjuvant treatment phase

Following surgery, an adjuvant treatment phase begins. This phase includes additional cycles of FOLFIRINOX and pembrolizumab to help prevent the cancer from returning.

The adjuvant treatment is similar to the initial treatment phase, with medications administered through infusions.

5 follow-up and monitoring

After completing all treatment phases, regular follow-up appointments are scheduled to monitor health and check for any signs of cancer recurrence.

These appointments may include physical exams, imaging tests, and blood tests to assess overall health and detect any changes.

Who Can Join the Study?

The patient must have pancreatic cancer confirmed by a test called a biopsy.
If the patient is a woman, she must not be pregnant or breastfeeding. If she can have children, she must agree to use birth control during the study and for at least 18 weeks after the last treatment.
The patient must provide written consent to participate in the study.
The patient must be at least 18 years old.
The patient must have a type of pancreatic tumor that is considered borderline resectable, meaning it might be possible to remove it with surgery.
The patient must be able to undergo surgery, radiotherapy (a type of treatment using radiation), and chemotherapy (a type of treatment using drugs).
The patient must have a certain level of white blood cells (WBC) and platelets, which are types of blood cells important for fighting infections and stopping bleeding.
The patient must have a certain level of hemoglobin, which is a protein in red blood cells that carries oxygen.
The patient must have good kidney function, measured by a test called E-GFR.
The patient must have a certain level of bilirubin, a substance made by the liver, or be planned for a procedure to help with bile drainage.
If the patient is a man, he must agree to use birth control during the study and for at least 18 weeks after the last treatment, and he must not donate sperm during this time.

Who Cannot Join the Study?

Patients who have a different type of cancer other than pancreatic cancer or borderline resectable pancreatic cancer (BRPC) cannot participate. BRPC is a type of pancreatic cancer that is close to major blood vessels, making surgery more challenging.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults, but specific age details are not provided here.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
Both men and women can participate, but if a patient does not identify as either, they may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Maastro	Maastricht	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Autrqgxfx Uwg	Amsterdam	The Netherlands
Encrdad Uxfymkhmlctx Mpdpenz Cgiuyca Rqgdorxrd (onoacqk Mzn	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.03.2024

Trial locations

Investigated drugs:

FOLFIRINOX is a combination of chemotherapy drugs used to treat pancreatic cancer. It works by stopping the growth of cancer cells and is often used before surgery to shrink tumors, making them easier to remove.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to enhance the body’s natural defenses against cancer.

Stereotactic Ablative Body Radiotherapy (SABR) is a type of radiation therapy that delivers high doses of radiation to a precise area. It is used to target and destroy cancer cells in the pancreas while minimizing damage to surrounding healthy tissue.

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 starts in the cells that produce digestive juices or hormones. The disease may not show symptoms in its early stages, making it difficult to detect early. As it progresses, it can cause symptoms like abdominal pain, weight loss, and jaundice. The cancer can spread to nearby organs and tissues, complicating treatment. It is known for its aggressive nature and rapid progression.

Borderline resectable pancreatic cancer (BRPC) – This form of pancreatic cancer is characterized by tumors that are close to major blood vessels, making surgical removal challenging but potentially possible. The tumors are not clearly resectable or unresectable, placing them in a borderline category. Treatment often involves a combination of therapies to shrink the tumor before attempting surgery. The disease can progress by invading nearby structures or spreading to distant sites. Symptoms may include pain, digestive issues, and weight loss. The goal is to manage the disease to allow for surgical intervention.

Trial ID:

2023-508707-20-00

Protocol code:

2023-508707-20-00

NCT ID:

NCT06384560

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on FOLFIRINOX, Pembrolizumab, and SABR for Patients with Borderline Resectable Pancreatic Cancer

What is this study about?

Who Can Join the Study?

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