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Study on Cisplatin, Gemcitabine, and Paclitaxel Albumin-Bound for Patients with Resectable Biliary Tract Cancer at High Risk of Recurrence

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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 biliary tract cancers, which are cancers that occur in the bile ducts, gallbladder, and other parts of the biliary system. The study is comparing two approaches for patients with these cancers who are at high risk of the cancer coming back after surgery. One group of patients will receive a combination of medications called Cisplatin, Gemcitabine Hydrochloride, and Paclitaxel Albumin-Bound as chemotherapy before surgery. The other group will have surgery right away without receiving these medications first. The purpose of the study is to see which approach is more effective in preventing the cancer from returning within 12 months.

Participants in the study will be randomly assigned to one of the two groups. Those receiving the chemotherapy will have the medications administered through an infusion, which means the drugs are given directly into the bloodstream through a vein. The chemotherapy treatment will last for a specific period before the surgery is performed. The study will monitor the patients' health and progress over time to determine the effectiveness of the treatment. Some patients may receive a placebo as part of the study, which is a substance with no active medication, to help compare the results.

The study aims to provide valuable information on whether receiving chemotherapy before surgery can improve outcomes for patients with biliary tract cancers. By comparing the two groups, researchers hope to find the best approach to reduce the risk of cancer recurrence and improve the quality of life for patients. The study will continue to follow participants for a period to gather comprehensive data on the long-term effects and benefits of the treatments being tested.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and follow the study protocol.

    You will undergo initial assessments to confirm eligibility, including tests to ensure your cancer is resectable and you meet other health criteria.

  2. Step 2

    Randomization

    You will be randomly assigned to one of two groups: one group will receive chemotherapy before surgery, and the other will proceed directly to surgery.

  3. Step 3

    Chemotherapy treatment

    If assigned to the chemotherapy group, you will receive a combination of medications: cisplatin, gemcitabine hydrochloride, and paclitaxel albumin-bound. These are administered through an infusion, which is a slow injection into a vein.

    The treatment will be given in cycles, with specific dosages and frequency determined by the study team. The duration of this phase will be communicated to you based on your individual treatment plan.

  4. Step 4

    Surgery

    After completing the chemotherapy phase, or if you are in the surgery group, you will undergo surgery to remove the cancer. The timing and details of the surgery will be planned by your medical team.

  5. Step 5

    Follow-up assessments

    Post-surgery, you will have regular follow-up assessments to monitor your health and the effectiveness of the treatment. These assessments may include scans and blood tests.

    Your quality of life will also be evaluated through questionnaires to understand the impact of the treatment on your daily activities and well-being.

  6. Step 6

    End of study participation

    Your participation in the study will continue until the study's end date or until you decide to withdraw. The study team will provide guidance on any further steps or treatments needed after the study concludes.

Who can join the trial?

19 criteria

  • The patient must be able and willing to provide written consent and follow the study rules and planned surgeries.
  • The patient must be between 18 and 74 years old.
  • The patient must have a confirmed diagnosis of a type of cancer in the bile ducts that can be surgically removed. This includes certain types of gallbladder cancer and bile duct cancer, but not mixed tumors with liver cancer or ampullary cancers.
  • A sample of the tumor must be available for testing.
  • The patient must have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • The patient must not have had any previous surgery to remove a bile duct tumor.
  • Scans like CT, MRI, and PET must show no spread of cancer to distant parts of the body.
  • The cancer must be considered technically removable by a team of specialists, including an oncologist, surgeon, radiologist, gastroenterologist, and pathologist, all with more than 3 years of experience in bile duct cancer.
  • The patient must be at high risk for cancer returning, based on certain risk features evaluated before surgery.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
  • Participants must agree not to donate eggs or sperm during the study and for 7 months after the last treatment. They should consider preserving eggs or sperm before treatment, as cancer treatments may affect fertility.
  • The patient must have an estimated life expectancy of more than 3 months.
  • The patient must have adequate blood health, including a certain level of white blood cells, platelets, and hemoglobin. Blood transfusions are allowed if needed.
  • The patient must have adequate liver function, with specific levels of bilirubin and liver enzymes.
  • The patient must have adequate kidney function, with a certain level of creatinine clearance.
  • The patient must have adequate blood clotting ability, with specific levels of INR and PTT, unless they are on blood-thinning medication.
  • The patient must not have a complete deficiency of the DPD enzyme, which is checked with a genetic test.
  • Women who can have children must agree to use highly effective birth control methods or abstain from sex during the study and for at least 7 months after the last treatment.
  • Men must agree to use highly effective birth control methods or abstain from sex during the study.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer that is not a resectable biliary tract cancer cannot participate. Resectable means that the cancer can be removed by surgery.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have a history of allergic reactions to the study medications cannot participate.
  • Patients who have a serious infection or other serious medical condition cannot participate.
  • Patients who are unable to give informed consent cannot participate. Informed consent means understanding the study and agreeing to participate.
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Investigated drugs

  • Cisplatin

    is a type of chemotherapy drug that is used to treat various types of cancer. It works by damaging the DNA in cancer cells, which prevents them from dividing and growing. In this trial, Cisplatin is being used as part of a combination therapy to help shrink tumors before surgery.

  • Gemcitabine

    is another chemotherapy medication that is used to treat different kinds of cancer. It works by interfering with the DNA of cancer cells, stopping them from growing and multiplying. In this study, Gemcitabine is combined with other drugs to enhance its effectiveness in reducing tumor size before surgery.

  • Nab-paclitaxel

    is a chemotherapy drug that is used to treat certain types of cancer. It is a form of paclitaxel that is bound to a protein called albumin, which helps it to be absorbed by the body more effectively. Nab-paclitaxel works by stopping cancer cells from dividing, which can help to shrink tumors. In this trial, it is used in combination with other drugs to improve treatment outcomes before surgery.

What is already known about the treatment

  • Cisplatin

    Cisplatin is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. It is a well-established chemotherapy drug used in the treatment of various cancers, including resectable biliary tract cancers. Cisplatin works by damaging the DNA in cancer cells, which prevents them from dividing and growing. It belongs to a class of drugs known as platinum-based antineoplastic agents.

  • Gemcitabine

    Gemcitabine is also given intravenously and is commonly used in combination with other chemotherapy drugs to treat different types of cancer, such as biliary tract cancers. It acts by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and multiplication. Gemcitabine is classified as an antimetabolite, a type of chemotherapy drug.

  • Nab-paclitaxel

    Nab-paclitaxel is administered through an intravenous infusion and is used in the treatment of various cancers, including biliary tract cancers. It works by stabilizing the structure of microtubules, which are part of the cell's skeleton, thus preventing cancer cells from dividing. Nab-paclitaxel is a member of the taxane family of chemotherapy drugs.

Investigated diseases

Resectable Biliary Tract Cancers – Biliary tract cancers originate in the bile ducts, gallbladder, or ampulla of Vater. These cancers can be classified based on their location as intrahepatic, perihilar, or distal. When termed "resectable," it means the cancer can potentially be removed entirely through surgery. The disease often progresses by spreading locally within the biliary system and may invade nearby organs. Over time, it can also metastasize to distant organs such as the liver or lungs. The progression of these cancers can lead to symptoms like jaundice, abdominal pain, and weight loss.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-503295-25-00Protocol codePURITYEstimated enrolment108 patientsSponsorFondazione GONO G.I.

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