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Study of melphalan followed by trifluridine-tipiracil and bevacizumab combination versus trifluridine-tipiracil and bevacizumab in liver metastatic colorectal cancer

Fast replyRegistered 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 Refractory Metastatic Colorectal Cancer where cancer has spread mainly to the liver. The study compares two treatment approaches. One group of patients will receive a combination of medications including Melphalan delivered directly to the liver, followed by treatment with Trifluridine-tipiracil and Bevacizumab. The other group will receive only Trifluridine-tipiracil and Bevacizumab without the liver-directed Melphalan treatment.

The main purpose of this research is to determine if adding Melphalan treatment to the liver before starting the combination of Trifluridine-tipiracil and Bevacizumab helps to better control cancer growth in the liver compared to using Trifluridine-tipiracil and Bevacizumab alone. Trifluridine-tipiracil is given as tablets by mouth, while Bevacizumab is given through an infusion into a vein.

Throughout the study, patients will have regular medical check-ups and imaging tests to monitor their cancer. These tests will help determine how well the treatment is working and track any changes in the cancer, both in the liver and elsewhere in the body. The study will continue until the cancer shows signs of growth or until other factors require stopping the 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 randomization

    You will be randomly assigned to one of two treatment groups:

    Group 1: Melphalan/HDS treatment followed by Trifluridine-tipiracil plus Bevacizumab

    Group 2: Trifluridine-tipiracil plus Bevacizumab alone

  2. Step 2

    Medical imaging

    You will undergo chest, abdomen, and pelvis CT scans

    An MRI scan of your liver will be performed

    These scans help monitor your condition throughout the treatment

  3. Step 3

    Treatment administration

    Group 1 patients receive:

    - Melphalan through a special injection procedure into the liver

    - After completion, treatment continues with Trifluridine-tipiracil tablets taken by mouth

    - Bevacizumab given through an intravenous infusion

    Group 2 patients receive:

    - Trifluridine-tipiracil tablets taken by mouth

    - Bevacizumab given through an intravenous infusion

  4. Step 4

    Regular monitoring

    Your liver condition will be regularly assessed

    Regular scans will track any changes in tumor size

    Your overall health status will be monitored throughout the study period

  5. Step 5

    Study duration

    The study continues until February 2027

    Your participation duration depends on how your condition responds to treatment

    Regular assessments will determine if the treatment should continue

Who can join the trial?

13 criteria

  • Must be 18 years or older at the time of giving consent
  • Women who can become pregnant must have a negative pregnancy test within 7 days before starting the study
  • Women who can become pregnant and men who are fertile must use effective birth control methods from the time of consent until at least 6 months after the last study treatment
  • Must provide signed informed consent
  • Must have confirmed colorectal cancer that has spread to the liver, with liver tumors taking up 50% or less of the liver
  • Must have cancer that is mainly in the liver that cannot be removed by surgery
  • Liver tumors must be measurable by CT scan or MRI
  • Must weigh at least 35 kg (77 pounds)
  • If cancer has spread outside the liver, it must be limited to:
    • Up to 5 lung tumors no larger than 2 cm each
    • Up to 5 lymph nodes no larger than 2 cm each
    • Must have recent scans (within 28 days) of chest, abdomen, and liver before starting the study
    • Must have previously received and either did not respond to or could not tolerate standard cancer treatments including chemotherapy and biological therapy
    • Must have good physical function ability (ECOG performance status of 0-1)

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 75 years
  • Previous treatment with trifluridine-tipiracil (a type of chemotherapy medication)
  • Active brain metastases (cancer that has spread to the brain)
  • Known allergies to study medications
  • Severe heart conditions or uncontrolled high blood pressure
  • Significant liver dysfunction not related to cancer
  • Active bleeding or high risk of bleeding
  • Major surgery within 4 weeks before starting the study
  • Pregnant or breastfeeding women
  • Active infections requiring systemic treatment
  • Other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Psychiatric or other conditions that could interfere with the ability to provide informed consent
  • Life expectancy less than 3 months
  • Participation in another clinical trial within 30 days before starting this study
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Investigated drugs

  • Melphalan

    is a chemotherapy medication used to treat various types of cancer. In this trial, it is delivered through a specialized system called HDS (Hepatic Delivery System) that targets the liver specifically. This method helps to deliver the medication directly to liver tumors while minimizing exposure to other parts of the body.

  • Trifluridine-tipiracil

    is an oral combination medication used to treat colorectal cancer. It works by interfering with cancer cell DNA, which helps stop or slow down the growth of cancer cells.

  • Bevacizumab

    is a targeted therapy that works by blocking the formation of new blood vessels that feed tumors. By reducing the blood supply to cancer cells, it can help slow down or stop tumor growth. It is given through an intravenous infusion and is commonly used in combination with other cancer treatments.

What is already known about the treatment

  • Melphalan

    A chemotherapy medication administered through high-dose hepatic arterial infusion (HDS) directly to the liver. This drug belongs to the alkylating agents class and works by interfering with DNA replication in cancer cells, preventing them from dividing and growing. It is currently used in clinical trials for treating liver-dominant metastatic colorectal cancer, showing promise when combined with other targeted therapies.

  • Trifluridine-tipiracil

    An oral combination medication used to treat metastatic colorectal cancer when other treatments have failed. This antineoplastic agent works by interfering with DNA function and blocking cell division, effectively stopping cancer growth. It represents a modern approach to treating advanced colorectal cancer and is typically used in combination with other cancer medications for improved efficacy.

  • Bevacizumab

    A targeted therapy medication administered through intravenous infusion that works by blocking the formation of new blood vessels that feed tumors. This monoclonal antibody specifically targets vascular endothelial growth factor (VEGF), helping to starve cancer cells of blood supply and nutrients. It is commonly used in combination with other cancer treatments for metastatic colorectal cancer and has shown significant effectiveness in clinical practice.

Investigated diseases

Metastatic Colorectal Cancer with Liver Dominant Disease - A form of colorectal cancer that has spread beyond its original location in the colon or rectum, with the liver being the main site of cancer spread. The disease begins in the large intestine (colon) or rectum and develops secondary tumors primarily in the liver tissue. This condition occurs when cancer cells from the primary colorectal tumor travel through the bloodstream or lymphatic system and establish new growth in the liver. The liver becomes the predominant site of cancer activity, though other organs may also be affected to a lesser extent. The disease typically develops gradually, with the liver metastases growing over time and potentially affecting liver function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520356-24-00Protocol codePHP-CRC-201Estimated enrolment96 patientsSponsorDelcath Systems Inc.

sourced from the EU Clinical Trials Register and site verification

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