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Study on Sequential Treatment with Gemcitabine, Paclitaxel, and FOLFIRINOX for Patients with Locally Advanced 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 treatments for locally advanced pancreatic cancer. The study involves a sequence of treatments starting with a combination of medications known as GEMBRAX and FOLFIRINOX. These are chemotherapy treatments that use different drugs to target cancer cells. The medications involved in this study include levoleucovorin disodium, gemcitabine, fluorouracil, paclitaxel albumin-bound, irinotecan hydrochloride trihydrate, and oxaliplatin. After the chemotherapy, patients will receive MRI-guided radiotherapy, which uses magnetic resonance imaging to help direct radiation precisely at the cancer.

The purpose of the study is to evaluate how effective the sequence of chemotherapy treatments is and to assess how well patients tolerate the radiotherapy. Participants will first receive the chemotherapy treatments, followed by the radiotherapy if their cancer has not progressed. The study will monitor patients over a period to see how the cancer responds to the treatments and to check for any side effects.

Throughout the study, the focus will be on understanding the benefits of the treatment sequence and ensuring the safety and well-being of the participants. The study aims to provide valuable information on the effectiveness of combining these treatments for patients with locally advanced pancreatic cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the treatment begins with a sequence called GEMBRAX. This involves the administration of two medications: gemcitabine and paclitaxel albumin-bound. Both medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

    The specific dosage and frequency of these medications will be determined by the healthcare team based on individual patient needs and responses.

  2. Step 2

    Transition to FOLFIRINOX

    After completing the GEMBRAX sequence, the treatment transitions to a regimen known as FOLFIRINOX. This involves a combination of four medications: levoleucovorin disodium, fluorouracil, irinotecan hydrochloride trihydrate, and oxaliplatin.

    These medications are also administered through intravenous infusion. The healthcare team will provide specific instructions regarding the dosage and schedule for each medication.

  3. Step 3

    Evaluation of treatment response

    Following the completion of the FOLFIRINOX sequence, an evaluation is conducted to assess the response to the treatment. This involves various tests and imaging studies to determine the effectiveness of the chemotherapy in controlling the cancer.

  4. Step 4

    Stereotactic MRI-guided radiotherapy

    If the cancer has not progressed, the next step involves stereotactic MRI-guided radiotherapy. This is a precise form of radiation therapy that uses MRI technology to target the cancerous area while minimizing exposure to surrounding healthy tissue.

    The duration and frequency of the radiotherapy sessions will be determined by the healthcare team based on the patient's specific condition and response to previous treatments.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring and follow-up appointments are scheduled to track the patient's progress and manage any side effects. This includes routine blood tests, imaging studies, and assessments of overall health and well-being.

    The healthcare team will provide guidance on managing any symptoms or side effects experienced during the trial.

Who can join the trial?

7 criteria

  • Patient must be between 18 and 75 years old on the date of signing the consent form.
  • Must have a confirmed diagnosis of pancreatic adenocarcinoma, which is a type of cancer in the pancreas, proven by specific tests called histology or cytology.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
  • The cancer must not be removable by surgery, as determined by specific guidelines.
  • The patient must not have cancer that has spread to other parts of the body, confirmed by specific scans of the chest, abdomen, and pelvis, as well as a liver MRI.
  • It must be possible to perform MRI-guided radiotherapy, confirmed by a review process.
  • The level of a specific marker in the blood called CA 19.9 must be less than 500 IU/mL, unless certain scans show no spread of cancer, in which case a level between 500 IU/mL and 1000 IU/mL may be acceptable. If the level is over 1000 IU/mL, the patient cannot participate.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides local advanced pancreatic adenocarcinoma cannot participate. This means the study is only for those with a specific type of pancreatic cancer.
  • Patients who have had previous treatments that might interfere with the study's treatment plan are not eligible.
  • Individuals with severe health conditions that could make it unsafe to participate in the study are excluded.
  • Patients who are unable to follow the study procedures or attend required visits cannot take part.
  • Pregnant or breastfeeding women are not allowed to participate to ensure the safety of the mother and child.
  • Patients who are participating in another clinical trial at the same time are not eligible.
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Investigated drugs

  • GEMBRAX

    is a combination of two chemotherapy drugs used to treat pancreatic cancer. It works by stopping the growth of cancer cells and is often used in patients with locally advanced pancreatic cancer. This treatment is part of a sequence to evaluate its effectiveness in controlling the disease.

  • FOLFIRINOX

    is another chemotherapy regimen that includes a combination of drugs. It is used to treat pancreatic cancer by attacking cancer cells in different ways, making it a powerful option for patients with advanced stages of the disease. This treatment follows GEMBRAX in the sequence to assess its impact on the cancer.

  • Stereotactic MRI-guided Radiotherapy

    is a type of radiation therapy that uses MRI technology to precisely target cancer cells in the pancreas. This therapy is used after the chemotherapy sequence in patients whose cancer has not progressed, aiming to further control the disease and improve outcomes.

What is already known about the treatment

  • Gembrax

    Gembrax is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally advanced pancreatic cancer. It is a combination chemotherapy regimen that includes gemcitabine and nab-paclitaxel. The main therapeutic indication is for pancreatic adenocarcinoma that has not spread beyond the pancreas. At the molecular level, Gembrax works by interfering with the DNA replication process in cancer cells, thereby inhibiting their growth and division. It is classified as an antineoplastic agent, specifically a combination of an antimetabolite and a taxane.

  • Folfirinox

    Folfirinox is administered intravenously and is also under investigation in clinical trials for its potential benefits in treating locally advanced pancreatic cancer. This regimen combines four chemotherapy drugs: folinic acid, fluorouracil, irinotecan, and oxaliplatin. It is primarily indicated for pancreatic adenocarcinoma that is locally advanced. The mechanism of action involves multiple pathways, including the inhibition of DNA synthesis and repair, leading to cancer cell death. Folfirinox is classified as a combination chemotherapy regimen, involving an antimetabolite, a topoisomerase inhibitor, and a platinum-based drug.

Investigated diseases

Pancreatic Adenocarcinoma – 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 is known for its aggressive nature and tendency to spread quickly to nearby organs. The disease often progresses silently, with symptoms appearing only in advanced stages. These symptoms may include jaundice, weight loss, and abdominal pain. As the cancer advances, it can obstruct the bile duct, leading to further complications. The progression of pancreatic adenocarcinoma is typically rapid, making early detection challenging.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515344-23-00Protocol codePROICM 2020-04 GABEstimated enrolment103 patientsSponsorInstitut Regional Du Cancer De Montpellier

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