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Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder 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 the effects of a treatment for patients who have undergone surgery for two types of cancer: cholangiocarcinoma and muscle invasive gallbladder carcinoma. Cholangiocarcinoma is a cancer that occurs in the bile ducts, which are small tubes that carry bile from the liver to the small intestine. Muscle invasive gallbladder carcinoma is a type of cancer that affects the gallbladder and has spread into the muscle layer. The treatment being studied involves the use of two medications, gemcitabine and cisplatin, which are given after surgery to help prevent the cancer from coming back. These medications are compared to the standard care, which may include observation or another medication called capecitabine.

The purpose of this study is to evaluate how effective the combination of gemcitabine and cisplatin is compared to the standard care in preventing the return of cancer after surgery. Patients participating in the study will receive either the combination of gemcitabine and cisplatin or the standard care, which could be observation alone or capecitabine, depending on the stage of their cancer. The study will monitor patients over a period to see how well the treatment works in keeping the cancer from returning and to assess the overall health and quality of life of the patients.

Participants in the study will receive treatment for a set period, and their health will be closely monitored by healthcare professionals. The study aims to provide valuable information on the best treatment options for patients who have had surgery for cholangiocarcinoma or muscle invasive gallbladder carcinoma. By comparing the new treatment with the standard care, researchers hope to find the most effective way to help patients live longer without the cancer returning.

The research process

The trial runs in 4 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, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of certain types of cancer and recent surgical treatment.

    Written informed consent is required before participation.

  2. Step 2

    Treatment phase

    The treatment phase involves receiving adjuvant chemotherapy with gemcitabine hydrochloride and cisplatin.

    Gemcitabine is administered as a solution for infusion through an intravenous route.

    Cisplatin is also given as a solution for infusion intravenously.

    The chemotherapy regimen is compared to the standard care, which may include observation or treatment with capecitabine tablets taken orally.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and any side effects.

    The primary goal is to evaluate disease-free survival and other outcomes such as overall survival and quality of life.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by the end of 2025.

    Final assessments will be made to determine the long-term benefits and safety of the treatment.

Who can join the trial?

18 criteria

  • Patients must have a type of cancer called **adenocarcinoma** of the **biliary tract** or **muscle invasive gallbladder carcinoma**. This means cancer that starts in the glands of the bile ducts or gallbladder.
  • Patients should be scheduled for surgery aimed at completely removing the cancer.
  • Patients must provide **written informed consent**, which means they agree to participate after understanding the study details.
  • Patients should not have had any previous **chemotherapy** for biliary tract cancer.
  • Patients should not have had any other cancer in the last 3 years, except for certain types like non-melanoma skin cancer or treated cervical cancer.
  • Patients should not have serious heart problems, such as severe heart failure, recent heart attack, or unstable chest pain.
  • Patients should not have mental health issues that prevent them from understanding the study or giving consent.
  • Patients should not have serious medical conditions that could affect their ability to participate in the study.
  • Women who can have children and men who can father children must agree to use effective birth control methods.
  • Women should not be pregnant or breastfeeding.
  • Patients must be at least 18 years old.
  • Patients must have good blood health, meaning enough white blood cells, platelets, and hemoglobin.
  • Patients must have good liver function, which is checked by certain blood tests.
  • Patients must have good kidney function, which is also checked by blood tests.
  • Patients should not have any active, uncontrolled infections, except for chronic viral hepatitis if they are receiving treatment for it.
  • Patients should not be taking other experimental drugs or cancer treatments within 30 days before starting the study.
  • Women who are not yet menopausal or are less than a year into menopause must have a negative pregnancy test before starting the study.
  • For a specific part of the study involving radiotherapy, patients must have a **microscopic positive margin** (R1) and no previous radiotherapy to the abdomen.

Who cannot join the trial?

5 criteria

  • Patients who have not had surgery to remove their cancer with the goal of curing it.
  • Patients with signs of cancer spreading to other parts of the body, known as **metastatic disease**.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a **vulnerable population**, which means they might need special protection or care.
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Investigated drugs

  • Gemcitabine

    is a medication used in this trial to help prevent the return of cancer after surgery. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body.

  • Cisplatin

    is another medication used in the trial alongside gemcitabine. It helps to kill cancer cells by damaging their DNA, which prevents them from dividing and growing.

  • Capecitabine

    is a medication that is used in the trial as part of the standard care in stage 2. It is an oral chemotherapy drug that is converted into another drug called 5-fluorouracil in the body, which helps to stop cancer cells from growing and dividing.

What is already known about the treatment

  • Gemcitabine

    This medication is administered intravenously and is used in the treatment of various cancers, including cholangiocarcinoma and gallbladder carcinoma. It is currently well-established in medical practice and literature as a chemotherapy agent. Gemcitabine works by interfering with DNA synthesis, thereby preventing cancer cells from multiplying. It belongs to the pharmacological class of antimetabolites.

  • Cisplatin

    Administered intravenously, cisplatin is used in combination with other drugs to treat several types of cancer, including cholangiocarcinoma and gallbladder carcinoma. It is a well-known and widely used chemotherapy drug. Cisplatin works by forming cross-links in DNA, which ultimately leads to cell death. It is classified as a platinum-based antineoplastic agent.

Investigated diseases

  • Cholangiocarcinoma

    Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can occur in different parts of the bile duct system, including intrahepatic (inside the liver), hilar (where the bile ducts exit the liver), or distal (closer to the small intestine). The disease often progresses slowly and may not show symptoms until it is advanced. As it develops, it can cause jaundice, abdominal pain, and weight loss. The cancer can spread to nearby tissues and organs, making it more challenging to treat as it progresses.

  • Gallbladder Carcinoma

    Gallbladder carcinoma is a cancer that originates in the gallbladder, a small organ beneath the liver that stores bile. This type of cancer is often discovered at a late stage because it may not cause noticeable symptoms early on. As the disease progresses, it can lead to symptoms such as abdominal pain, nausea, and jaundice. The cancer can invade nearby organs and tissues, complicating treatment efforts. It is more common in individuals with a history of gallstones or chronic gallbladder inflammation. The progression of the disease can vary, but it typically involves the spread to surrounding areas.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517340-61-00Protocol codeACTICCA-1Estimated enrolment850 patientsSponsorUniversity Medical Center Hamburg-Eppendorf

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