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Study of Gemcitabine with Paclitaxel versus Standard Chemotherapy Combination for Patients with Borderline Resectable Pancreatic Cancer Based on Gene Analysis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with borderline resectable pancreatic adenocarcinoma, which is a type of pancreatic cancer that may be surgically removed after initial treatment. The study aims to evaluate the effectiveness of different chemotherapy combinations based on specific genetic markers in the tumor tissue before surgery.

The study uses several chemotherapy medications including gemcitabine, paclitaxel, fluorouracil, irinotecan, oxaliplatin, and folinic acid. Some patients will receive a combination of gemcitabine and paclitaxel, while others will receive a combination of the other medications. The choice of treatment will be based on specific genetic patterns found in the tumor tissue.

The treatment involves receiving chemotherapy for 4 months before surgery. After surgery, patients will continue to be monitored to evaluate how well the treatment worked. Throughout the study, doctors will track various measures of treatment success, including whether the cancer returns and how long patients live without the disease getting worse.

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

    Initial evaluation

    A medical team will confirm your diagnosis of borderline resectable pancreatic cancer through CT scan evaluation

    Your tumor tissue sample will be analyzed to determine its specific characteristics

    Basic health tests will be performed to check your organ function, including blood tests

  2. Step 2

    Treatment assignment

    Based on your tumor's characteristics, you will receive one of two treatment options:

    Option 1: Gemcitabine with Paclitaxel administered through intravenous infusion

    Option 2: mFOLFIRINOX treatment (combination of fluorouracil, folinic acid, irinotecan, and oxaliplatin) administered through intravenous infusion

  3. Step 3

    Initial treatment phase

    You will receive treatment for 4 months before potential surgery

    Regular evaluations will monitor your response to treatment

    Blood tests and imaging scans will be performed to track your progress

    Side effects will be monitored and documented before each treatment cycle

  4. Step 4

    Surgical evaluation

    After the initial 4-month treatment period, your medical team will evaluate if surgery is possible

    If surgery is appropriate, the procedure will be scheduled

  5. Step 5

    Follow-up care

    Regular check-ups will continue to monitor your health

    Quality of life assessments will be conducted using standard questionnaires

    Your progress will be tracked until the study end date in April 2031

Who can join the trial?

16 criteria

  • Age between 18 and 80 years old (for patients 75-80, a geriatric evaluation is required)
  • Diagnosed with borderline resectable pancreatic ductal adenocarcinoma, confirmed by CT scan and reviewed by a medical team
  • Must have a tumor tissue sample available with more than 10% tumor cells
  • No previous cancer treatments (chemotherapy or radiation) for pancreatic cancer
  • Good overall physical condition (WHO Performance Status of 0 or 1, meaning able to perform daily activities)
  • Adequate organ function, including:
    • Liver tests (AST and ALT) less than 3.5 times normal limits
    • Bilirubin less than 3 times normal limits
    • Albumin above 30 g/L
    • Hemoglobin above 9.0 g/dl
    • White blood cells (neutrophils) above 1.5 G/L
    • Platelets above 100 G/L
    • Kidney function (creatinine clearance) above 50 mL/min
    • Must use contraception during treatment:
      • Women: during treatment and 15 months after
      • Men: during treatment and 12 months after
      • Must be able to follow study requirements, including scheduled visits and examinations
      • Must provide written informed consent before starting the study

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 75 years
  • Previous treatment with chemotherapy or radiation therapy for pancreatic cancer
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Significant heart problems or uncontrolled heart disease
  • Active or uncontrolled infections
  • Known allergies to Gemcitabine or Nab-Paclitaxel (chemotherapy medications used in the study)
  • Pregnancy or breastfeeding
  • Severe kidney or liver dysfunction
  • Participation in other clinical trials within 30 days before starting this study
  • Psychological, family, sociological, or geographical conditions that would prevent proper follow-up and compliance with the study protocol
  • Any other serious medical condition that could interfere with safe participation in the trial
  • Unable to provide informed consent
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Investigated drugs

  • Gemcitabine

    is a chemotherapy medication used to treat various types of cancer, including pancreatic cancer. It works by interfering with cancer cell growth and division, helping to slow or stop the spread of cancer cells.

  • Nab-paclitaxel

    (also known as albumin-bound paclitaxel) is a chemotherapy drug that targets and kills cancer cells by preventing them from dividing. It is bound to a protein called albumin, which helps deliver the medication more effectively to cancer cells.

  • FOLFIRINOX

    is a combination chemotherapy treatment that contains multiple medications working together to fight cancer. This treatment combines different drugs that work in various ways to kill cancer cells and prevent them from growing and spreading.

What is already known about the treatment

  • Gemcitabine

    A chemotherapy medication administered intravenously that is widely used in the treatment of pancreatic cancer, particularly in combination with other drugs. This nucleoside analog works by interfering with DNA synthesis in cancer cells, preventing them from dividing and multiplying. It belongs to the antimetabolite class of chemotherapy drugs and is considered a standard treatment option in pancreatic adenocarcinoma therapy.

  • Nab-paclitaxel

    An injectable chemotherapy drug that combines paclitaxel with albumin nanoparticles, allowing better delivery of the medication to cancer cells. This medication works by stopping cancer cell division through disruption of the cell's internal skeleton structure. It is commonly used in combination with gemcitabine for treating pancreatic cancer and belongs to the taxane family of chemotherapy drugs.

  • FOLFIRINOX

    A combination chemotherapy regimen administered intravenously that consists of four drugs (fluorouracil, leucovorin, irinotecan, and oxaliplatin). This powerful treatment protocol is considered a standard of care in pancreatic cancer treatment, working through multiple mechanisms to kill cancer cells by interfering with DNA replication and cell division. It represents one of the most effective but also more intensive chemotherapy options for pancreatic cancer treatment.

Investigated diseases

  • Pancreatic Ductal Adenocarcinoma

    A type of cancer that begins in the cells lining the ducts of the pancreas. The disease typically starts in the pancreatic ducts and can gradually spread to nearby tissues. In its borderline resectable form, the tumor has limited involvement with nearby blood vessels but may still be surgically removable. The condition often develops slowly at first, potentially affecting the pancreas's ability to produce digestive enzymes and hormones. As the disease progresses, it can affect surrounding tissues and organs.

  • Borderline Resectable Pancreatic Cancer

    A specific classification of pancreatic cancer where the tumor shows limited involvement with nearby blood vessels. This condition represents an intermediate stage between clearly resectable and unresectable pancreatic cancer. The tumor touches or wraps around nearby blood vessels but does so in a way that might still allow for surgical removal. The disease affects the pancreas and its immediate surrounding structures.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519753-11-00Protocol codePRODIGE 104 AEstimated enrolment110 patientsSponsorFondation Franc.Cancerologie Digestive

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).