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Testing trifluridine, tipiracil and nanoliposomal irinotecan combination for patients with bile duct or gallbladder cancer after previous treatment

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What is this trial about?

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

This study examines cholangiocarcinoma and gallbladder carcinoma, which are cancers that develop in the bile ducts or the gallbladder. The study focuses on patients whose cancer has spread or cannot be removed by surgery and who have previously received treatment with gemcitabine, a type of cancer medicine, but their disease has gotten worse or they could not tolerate that treatment. The treatment being studied combines two medications: Lonsurf, which contains trifluridine and tipiracil hydrochloride and is taken by mouth as tablets, and Onivyde, which contains irinotecan in a special form called pegylated liposomal and is given through a vein as an infusion.

The purpose of this study is to examine how well this combination of trifluridine/tipiracil and nanoliposomal irinotecan works in treating patients with advanced cholangiocarcinoma or gallbladder carcinoma after their previous gemcitabine-based treatment has failed. The study will look at how long patients can go without their disease getting worse, which is measured from the time they start the study treatment until their cancer grows or spreads, or until death occurs. The study will also evaluate how long patients survive overall, how many patients experience shrinkage of their tumors, what side effects occur and how serious they are, and how the treatment affects patients' quality of life.

During the study, patients will receive the combination treatment and will be regularly checked to see how their disease is responding. Doctors will use imaging tests to monitor the cancer and will assess any side effects that occur. The study will also use questionnaires to understand how the treatment affects patients' daily life and well-being. Patients who have had testing to identify specific changes in their tumor may only join the study if they are not suitable for other approved targeted treatments or if they choose not to receive those treatments.

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

    Treatment cycle administration

    The treatment will be given in repeated cycles. Each cycle consists of a specific combination of medications given at scheduled times.

    Two medications will be administered during the trial: trifluridine/tipiracil (also known as Lonsurf) and nanoliposomal irinotecan (also known as Onivyde).

    Trifluridine/tipiracil is a medication taken by mouth in the form of film-coated tablets. It is available in two strengths: 15 mg/6.14 mg tablets and 20 mg/8.19 mg tablets.

    Nanoliposomal irinotecan is a medication given through a vein (intravenous infusion). It is a special form of the drug irinotecan that is enclosed in tiny fat particles called liposomes.

  2. Step 2

    Disease monitoring and assessment

    Throughout the trial, the response of the disease to treatment will be monitored regularly using imaging scans and clinical assessments.

    The medical team will evaluate whether the tumor is growing, shrinking, or staying the same size according to standardized criteria called RECIST 1.1, which is a set of rules used to measure tumors.

    These assessments will continue from the start of treatment until the disease progresses or until death, whichever occurs first.

  3. Step 3

    Safety monitoring

    During the trial, any side effects or unwanted reactions to the medications will be carefully recorded and evaluated.

    The type, frequency, and severity of side effects will be classified according to a standardized system called NCI CTCAE version 5.0, which is a common scale used to grade the severity of side effects.

    Special attention will be given to serious side effects and unexpected reactions to ensure patient safety throughout the trial.

  4. Step 4

    Quality of life assessment

    At regular intervals during the trial, questionnaires will be completed to assess general well-being and quality of life.

    Two standardized questionnaires will be used: EORTC QLQ-C30, which is a cancer-specific quality of life questionnaire, and EQ-5D-5L, which is a general health status questionnaire.

    These assessments help to understand how the treatment affects daily life and overall well-being.

  5. Step 5

    Follow-up period

    After treatment begins, follow-up will continue to track survival and long-term outcomes.

    The medical team will monitor the time from the start of treatment until disease progression and the overall survival time.

    A specific assessment will be made at 4 months after starting treatment to determine whether the disease has progressed or remained stable.

Who can join the trial?

7 criteria

  • You must have cholangiocarcinoma (a cancer that starts in the bile ducts, which are tubes that carry digestive fluid) or gallbladder carcinoma (cancer of the gallbladder) that has been confirmed by examining tissue or cells under a microscope
  • Your cancer must be non-resectable (cannot be removed by surgery), locally advanced (has grown into nearby areas), or metastatic (has spread to other parts of the body)
  • Your cancer must be measurable or assessable according to a standard system called RECIST 1.1, which means doctors can track the size of your tumors using scans
  • Your cancer must have gotten worse after previous treatment with gemcitabine (a type of chemotherapy medicine) or a treatment containing gemcitabine, or you were unable to tolerate such treatment
  • If you have had molecular tumor profiling (special testing to look at the genetic makeup of your cancer), you can only join this study if you are not eligible for other approved targeted treatments based on those test results, or if you choose not to receive those approved targeted treatments
  • You can be male or female
  • You must be an adult

Who cannot join the trial?

4 criteria

  • The specific exclusion criteria (reasons why you cannot participate in this study) have not been provided in the available information
  • To find out if you are not eligible for this study, you will need to discuss your individual medical situation with the research team
  • Generally, clinical trials have certain requirements about previous treatments, other health conditions, and test results that may prevent participation
  • Your doctor will review your complete medical history to determine if this study is appropriate for you
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Investigated drugs

  • Trifluridine/tipiracil

    is a combination medication used to treat cancer. It works by interfering with the growth of cancer cells, helping to slow down or stop the spread of the disease in your body.

  • Nanoliposomal irinotecan

    is a chemotherapy medication that is packaged in tiny fat particles called liposomes. This special packaging helps deliver the cancer-fighting medicine directly to tumor cells while reducing side effects on healthy cells. It works by damaging the DNA inside cancer cells, which prevents them from growing and dividing.

What is already known about the treatment

  • Trifluridine/Tipiracil

    This medication is given by mouth in tablet form and is currently approved for use in certain types of cancer treatment. It is being studied as a second-line therapy for patients with advanced bile duct or gallbladder cancer who did not respond to previous gemcitabine treatment. The drug works through a combination of two components: trifluridine, which gets incorporated into cancer cell DNA and stops the cells from dividing and growing, and tipiracil, which prevents the breakdown of trifluridine in the body, allowing it to remain active longer and reach the tumor more effectively.

  • Nanoliposomal Irinotecan

    This medication is administered directly into a vein through an intravenous infusion and is currently used in clinical practice for treating certain cancers. It is being investigated as a second-line treatment option for patients with advanced bile duct or gallbladder cancer whose disease progressed after gemcitabine-based therapy. The drug consists of irinotecan wrapped in tiny fat particles called liposomes, which help deliver the chemotherapy agent to cancer cells where it converts into its active form and damages the DNA of cancer cells, preventing them from multiplying and ultimately causing the cancer cells to die.

Investigated diseases

  • Cholangiocarcinoma

    Cholangiocarcinoma is a cancer that develops in the bile ducts, which are thin tubes that carry digestive fluid called bile from the liver to the small intestine. This type of cancer can occur anywhere along the bile ducts, either inside or outside the liver. As the disease progresses, the tumor grows and may block the bile ducts, causing bile to build up in the liver. The cancer can spread to nearby tissues and organs or to distant parts of the body through the bloodstream or lymphatic system. In advanced stages, the tumor cannot be removed by surgery and may have already spread to other areas of the body. Patients may experience symptoms such as yellowing of the skin and eyes, abdominal pain, weight loss, and fever.

  • Gallbladder Carcinoma

    Gallbladder carcinoma is a cancer that begins in the gallbladder, a small organ located beneath the liver that stores bile. The disease often develops slowly and may not cause symptoms in its early stages, making it difficult to detect. As the cancer grows, it invades the muscular wall of the gallbladder and can extend into the liver and nearby organs. The tumor may spread to lymph nodes in the area and eventually to distant parts of the body such as the lungs or bones. In advanced stages, the cancer cannot be surgically removed and may have already spread beyond the gallbladder. Symptoms that may appear include abdominal pain, nausea, vomiting, and yellowing of the skin and eyes.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517330-18-00Protocol codeTRITICC-2Estimated enrolment38 patientsSponsorHeinrich-Heine-Universitaet Duesseldorf

sourced from the EU Clinical Trials Register and site verification

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