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Study of drug combination therapy after surgery in patients with resectable pancreatic ductal adenocarcinoma using lab-grown mini-tumors to guide treatment selection

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 study focuses on patients with pancreatic ductal adenocarcinoma (PDAC) who have had surgery to remove their tumor. The research aims to use laboratory-grown miniature versions of tumors, called organoids, created from patients' cancer tissue to predict which chemotherapy treatment will work best for each individual after surgery.

The study involves several chemotherapy medications that are commonly used to treat pancreatic cancer. These include capecitabine, paclitaxel, irinotecan, gemcitabine, fluorouracil, oxaliplatin, and calcium folinate. Some medications are given by mouth, while others are administered through an intravenous line. The treatment period typically lasts for 6 months.

The research is divided into two parts. The first part checks if it's possible to grow these mini-tumors and test different chemotherapy combinations on them within 12 weeks after surgery. The second part examines how well patients do when their treatment is chosen based on how their laboratory-grown tumor responds to different chemotherapy combinations. The effectiveness of the treatment will be measured by tracking how long patients remain free of cancer after treatment.

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 participation confirmation

    After pancreatic cancer surgery, your tissue sample will be used to create organoids (miniature laboratory versions of your tumor).

    The organoids will be tested to determine which chemotherapy might work best in your case.

  2. Step 2

    Medical assessment

    Your doctor will check if you meet health requirements, including:

    - Blood test results within specific ranges

    - Kidney function showing creatinine clearance of 30 ml/min or higher

    - Liver function tests within acceptable limits

    - No signs of cancer spread after surgery

    - General health status allowing for chemotherapy

  3. Step 3

    Treatment initiation

    Treatment must begin within 12 weeks after surgery.

    Based on organoid testing results, you will receive one of these chemotherapy combinations:

    - mFOLFIRINOX: combination of fluorouracil, oxaliplatin, irinotecan, and calcium folinate given through vein

    - Gemcitabine: given through vein

    - Capecitabine: taken as tablets

    - Gemcitabine with capecitabine: combination of both medications

  4. Step 4

    Monitoring period

    Regular check-ups will monitor your progress for at least 18 months.

    You will complete quality of life questionnaires during this period.

    Regular scans and blood tests will check for any signs of cancer return.

  5. Step 5

    Safety requirements

    If you can become pregnant or father a child, you must use effective birth control during treatment and for 15 months afterward.

    Regular blood tests will monitor your body's response to treatment.

    Your doctor will check for and manage any side effects of the treatment.

Who can join the trial?

11 criteria

  • Must be 18 years or older
  • Must have pancreatic ductal cancer that can be surgically removed
  • Must have a Ca19-9 blood test result below 500 U/ml (Ca19-9 is a tumor marker used to monitor pancreatic cancer)
  • Must have good physical performance (ECOG score 0-1, meaning able to carry out light daily activities)
  • Must have adequate kidney function (creatinine clearance of 30 ml/min or higher)

  • Must have acceptable liver function tests:

    • Bilirubin levels between 1.5-3 times the normal limit
    • ALT and AST (liver enzymes) no more than 2.5 times the normal limit

  • Must have adequate blood cell counts:

    • White blood cells: 3.5 million or more per milliliter
    • Neutrophils (type of white blood cells): 1.5 million or more per milliliter
    • Platelets: 100 million or more per milliliter
  • Must be able to start chemotherapy within 12 weeks after surgery
  • Must have no signs of cancer spread to other organs (like liver, lung, or abdomen lining)
  • If able to have children, must agree to use effective birth control methods during treatment and for 15 months after the last treatment
  • Must provide signed informed consent to participate in the study

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 75 years
  • Presence of pancreatic cancer that cannot be surgically removed
  • Ca19-9 (a blood tumor marker) level higher than 500 U/ml
  • Significant cholestasis (a condition where bile cannot flow from the liver to the small intestine)
  • Not meeting the NCCN criteria (standard guidelines for cancer treatment)
  • Unable to provide informed consent
  • Pregnancy or breastfeeding
  • Participation in other clinical trials
  • Active, uncontrolled infections
  • Serious heart, liver, or kidney conditions that could interfere with treatment
  • History of other cancers in the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Mental conditions that could prevent following study procedures
  • Known allergies to study medications
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Investigated drugs

  • Capecitabine

    is an oral chemotherapy drug that is turned into 5‑fluorouracil inside the body. In this trial it is used after surgery to try to kill any remaining cancer cells and reduce the chance that the pancreatic cancer comes back.

  • Gemcitabine

    is a chemotherapy medicine given through a vein. It works by stopping cancer cells from growing and dividing. In the study it is part of the treatment given after the tumor has been removed, aiming to prevent the disease from returning.

  • Oxaliplatin

    is an intravenous chemotherapy drug that damages the DNA of cancer cells, making it harder for them to multiply. It is combined with other medicines after surgery to improve the chances of keeping the cancer away.

  • Paclitaxel

    is a chemotherapy agent administered by IV that stops cancer cells from dividing by interfering with their internal skeleton. In this trial it is used as part of the post‑surgical regimen to help keep the disease from coming back.

  • Calcium folinate

    is a vitamin‑type medication given intravenously that enhances the effect of certain chemotherapy drugs, especially fluorouracil. In the study it is used together with other chemotherapy to make the treatment more effective against any leftover cancer cells.

  • Fluorouracil

    (5‑FU) is a chemotherapy drug given through a vein that stops cancer cells from making DNA and RNA, which they need to grow. In the trial it is used after surgery, often with calcium folinate, to try to eliminate hidden cancer cells.

What is already known about the treatment

  • CAPECITABINE

    This medication is taken by mouth as a tablet and is absorbed and changed inside the body into the active drug 5‑fluorouracil. It is an approved cancer medicine used for colon, breast and stomach cancers and is being studied as an adjuvant treatment for pancreatic cancer. It works by blocking an enzyme needed for DNA building blocks, which stops cancer cells from multiplying. It belongs to the antimetabolite class of chemotherapy drugs.

  • GEMCITABINE HYDROCHLORIDE

    Given by intravenous infusion, this drug is a standard treatment for pancreatic, lung and breast cancers. It is a well‑known chemotherapy agent that is converted inside cells into a molecule that looks like a building block of DNA, causing the DNA chain to stop growing. By preventing DNA replication, it kills rapidly dividing cancer cells. It is classified as a nucleoside analog antimetabolite.

  • OXALIPLATIN

    Administered through an IV infusion, oxaliplatin is approved for colorectal cancer and is commonly combined with other drugs for pancreatic cancer treatment. It is a platinum‑based compound that creates strong links between DNA strands, making it impossible for cancer cells to copy their DNA. This DNA cross‑linking leads to cell death. It is categorized as a platinum‑based alkylating agent.

  • PACLITAXEL

    This chemotherapy drug is given by intravenous infusion and is approved for breast, ovarian, lung and pancreatic cancers. It works by binding to tiny structures called microtubules inside cells and keeping them from breaking apart, which stops cancer cells from dividing. The result is the death of the growing tumor cells. Paclitaxel belongs to the taxane class of mitotic inhibitors.

  • CALCIUM FOLINATE

    Delivered by IV infusion, calcium folinate is used to boost the effect of fluorouracil and to treat low folate levels. It supplies a reduced form of folate that helps fluorouracil bind more tightly to its target enzyme, increasing the drug’s ability to stop DNA production in cancer cells. This supportive role improves the overall chemotherapy effect. It is classified as a folinic acid (leucovorin) rescue agent.

  • FLUOROURACIL

    Given intravenously, fluorouracil is a long‑standing chemotherapy approved for many solid tumors, including pancreatic cancer. It mimics a normal DNA component and blocks the enzyme thymidylate synthase, which is needed to make new DNA. Without this enzyme, cancer cells cannot grow and eventually die. It is an antimetabolite belonging to the pyrimidine analog group.

Investigated diseases

Pancreatic Ductal Adenocarcinoma (PDAC) - A type of cancer that begins in the cells lining the ducts of the pancreas. It develops when cells in the pancreatic ducts begin to grow uncontrollably, forming a tumor. The disease typically progresses by growing locally within the pancreas and can spread to nearby structures. PDAC can affect the pancreas's ability to produce digestive enzymes and hormones that regulate blood sugar. The cancer cells can form masses that interfere with normal pancreatic function and may spread to other parts of the body. This type of cancer often develops gradually, and early stages may not cause noticeable symptoms.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510490-34-00Protocol codeUNITEPANCEstimated enrolment92 patientsSponsorUniversitaetsklinikum Ulm AöR

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