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Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary 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 advanced biliary cancer, a type of cancer that affects the bile ducts. The trial aims to compare a personalized treatment approach using specific medications to the standard treatment currently used for this condition. The medications being studied include Cisplatin, Durvalumab (known as IMFINZI), Trastuzumab (known as Zercepac), Futibatinib, Niraparib (also known as MK-4827), Neratinib (known as Nerlynx), Binimetinib (known as Mektovi), Zanidatamab (known as JZP598), Encorafenib (known as Braftovi), and Ivosidenib. Some patients will receive a placebo as part of the study.

The purpose of the study is to determine if the personalized treatment approach is more effective in preventing the cancer from getting worse compared to the standard treatment. Participants will first receive four cycles of the standard treatment. After this, they will be randomly assigned to either continue with the standard treatment or switch to a personalized treatment based on the specific characteristics of their cancer. The study will monitor the participants' health and the progression of their cancer over time.

Throughout the study, participants will undergo regular health assessments to track their response to the treatment. The study will last for several months, and participants will be closely monitored by healthcare professionals to ensure their safety and well-being. The ultimate goal is to find out if the personalized treatment can help patients live longer without their cancer progressing.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, a written informed consent form must be signed. This is to confirm understanding and agreement to participate in the study.

  2. Step 2

    Screening phase

    During the screening phase, eligibility is assessed. This includes confirming a diagnosis of advanced biliary cancer and ensuring the presence of a suitable tumor sample for analysis.

    Basic health assessments are conducted, including blood tests and imaging, to ensure adequate organ function and overall health status.

  3. Step 3

    Initial treatment

    The initial treatment involves receiving four cycles of the first-line standard of care (1L-SoC) therapy. This is a common treatment for advanced biliary cancer.

    The response to this treatment is monitored to determine if the disease is stable or responsive.

  4. Step 4

    Randomization

    If the disease is stable or responsive after the initial treatment, randomization occurs. This means being assigned to either continue with the standard treatment or switch to a targeted maintenance therapy based on the tumor's molecular profile.

  5. Step 5

    Maintenance therapy

    If assigned to the targeted maintenance therapy, specific medications are administered. These may include oral medications like futibatinib, neratinib, or binimetinib, or intravenous medications like cisplatin or gemcitabine.

    The dosage and frequency depend on the specific medication and the treatment plan outlined by the healthcare team.

  6. Step 6

    Ongoing monitoring

    Regular visits are scheduled to monitor health status and response to treatment. This includes physical exams, blood tests, and imaging studies.

    Adjustments to the treatment plan may be made based on these assessments.

  7. Step 7

    End of trial participation

    Participation in the trial continues until the end of the study period or until it is determined that the treatment is no longer effective.

    At the end of participation, a final assessment is conducted to evaluate overall health and treatment outcomes.

Who can join the trial?

21 criteria

  • Must be diagnosed with Advanced Biliary Cancer (ABC).
  • Must be at least 18 years old.
  • Must have signed a written informed consent form before any trial-specific procedures.
  • Must have a molecular profile showing the tumor has at least one targetable molecular change that can be treated with a study drug.
  • Must have disease control (stable or responsive) after 4 cycles of first-line standard of care treatment, as assessed by the doctor.
  • Must have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have at least one evaluable lesion according to specific medical criteria, or a complete response to 12 weeks of first-line standard of care treatment.
  • Must have adequate bone marrow function, which includes specific levels of blood cells and hemoglobin.
  • Must have adequate liver function, with specific levels of liver enzymes and bilirubin.
  • Must have adequate renal function, with a certain level of creatinine clearance, which measures kidney function.
  • Must have adequate cardiac function, with a left ventricular ejection fraction of at least 50%, which measures how well the heart pumps blood.
  • Must have adequate biliary drainage with no ongoing infection.
  • Must have a histologically-proven diagnosis of specific types of biliary cancer, excluding ampullary carcinoma.
  • Men and women of childbearing potential must agree to use adequate contraception during the trial and for a specified period after.
  • Women of childbearing potential must have a negative pregnancy test within 3 days before randomization.
  • Must be willing and able to comply with the study protocol, including visits, treatment plans, and tests.
  • Must be affiliated with a social security system or have equivalent private health insurance.
  • Must have de novo or recurrent, locally advanced (non-resectable) or metastatic disease.
  • Must have a suitable tumor tissue sample available or be able to undergo a biopsy to obtain one.
  • Must have an estimated life expectancy of more than 3 months.
  • Must be a candidate for first-line standard of care therapy or have started the first cycle of this therapy.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides Advanced Biliary Cancer (ABC) cannot participate.
  • Patients who have not completed 4 cycles of the first-line standard of care treatment (1L-SoC) are excluded.
  • Patients who have not responded to the first-line standard of care treatment (1L-SoC) are not eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to comply with the study procedures are not eligible.
  • Patients with known allergies to the study medication or its components are excluded.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.
  • Patients with any condition that the study doctors believe would make participation unsafe are not eligible.
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Investigated drugs

  • Molecular Targeted Therapy (MTT)

    is a type of treatment that uses drugs or other substances to precisely identify and attack cancer cells, usually while doing little damage to normal cells. In this trial, MTTs are used to target specific molecules involved in the growth and spread of cancer cells in patients with advanced biliary cancer. The goal is to see if these therapies can help stop the cancer from progressing after initial treatment.

  • Standard of Care (SoC)

    refers to the regular treatment that is currently accepted and widely used by medical professionals for a particular type of cancer. In this trial, the standard of care is used as a comparison to see if the new molecular targeted therapies are more effective in preventing the cancer from getting worse.

What is already known about the treatment

Molecular Targeted Therapy (MTT) – This medication is administered as a maintenance treatment for patients with advanced biliary cancer, typically after initial standard chemotherapy. It is currently being studied in clinical trials to determine its effectiveness in prolonging the time patients live without their cancer worsening. The main therapeutic indication is advanced biliary cancer, a type of cancer that affects the bile ducts. At the molecular level, MTT works by targeting specific molecules involved in the growth and spread of cancer cells, thereby inhibiting their function and slowing down the progression of the disease. It falls under the pharmacological classification of targeted cancer therapies, which are designed to interfere with specific pathways or proteins that are crucial for cancer cell survival and proliferation.

Investigated diseases

Advanced Biliary Cancer – Advanced Biliary Cancer is a type of cancer that occurs in the bile ducts, which are the channels that carry bile from the liver to the small intestine. This cancer can develop in different parts of the bile duct system, including inside the liver, outside the liver, or at the junction where the bile ducts meet. As the disease progresses, it can cause blockages in the bile ducts, leading to jaundice, which is a yellowing of the skin and eyes. Patients may also experience abdominal pain, weight loss, and changes in liver function. The cancer can spread to nearby organs and tissues, complicating the condition further. Over time, the disease can lead to significant liver damage and other systemic effects.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508100-38-00Estimated enrolment1 100 patientsSponsorUnicancer

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