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A study of futibatinib combined with tislelizumab, fluorouracil, calcium folinate, and oxaliplatin as first-line treatment for patients with colorectal cancer

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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 colorectal cancer that has spread or cannot be removed by surgery. The research evaluates a new combination treatment approach using several medications. The main drug being studied is futibatinib, which is given as tablets, along with tislelizumab (given through an infusion into a vein) and additional chemotherapy medications including fluorouracil, oxaliplatin, and calcium folinate.

The purpose of the study is to determine how effective this combination of medications is when used as a first treatment for colorectal cancer. During the study, participants will receive the study medications for up to 12 months. Futibatinib is taken by mouth daily, while the other medications are given through intravenous infusions at regular intervals.

Throughout the study, doctors will monitor how the cancer responds to treatment using imaging scans. They will also track any side effects and assess how the treatment affects patients' quality of life. The study will evaluate whether tumors shrink or disappear with this treatment combination, how long any improvements last, and how long patients live without their cancer getting worse.

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 treatment combination

    You will receive a combination of treatments including futibatinib tablets taken by mouth, along with three medications given through an intravenous (IV) line:

    - Tislelizumab (given as an IV infusion)

    - Fluorouracil (also known as 5-FU, given as an IV infusion)

    - Oxaliplatin (given as an IV infusion)

    An additional medication called calcium folinate will be given through IV to help manage treatment effects

  2. Step 2

    Regular health assessments

    Your health status will be monitored through regular medical examinations

    Doctors will measure how your tumor responds to treatment using imaging scans

    Blood tests will be performed to check your blood count, liver function, and kidney function

    Your calcium and phosphate levels will be monitored regularly

  3. Step 3

    Quality of life evaluation

    You will complete quality of life questionnaires during the study

    These assessments help track how the treatment affects your daily life and well-being

  4. Step 4

    Safety monitoring

    Regular checks will be performed to monitor any side effects

    Your doctor will assess if any dose adjustments are needed based on how your body responds to the treatment

  5. Step 5

    Treatment duration

    The treatment will continue as long as it provides benefit and is well-tolerated

    The study is planned to run until July 2028

    After completing treatment, you will have follow-up visits to monitor your health status

Who can join the trial?

15 criteria

  • Must provide signed informed consent to participate in the study
  • Must be 18 years or older when giving consent
  • Must be able to follow study requirements, including treatment, scheduled visits, examinations and follow-up
  • Must have confirmed colorectal adenocarcinoma (a type of colon cancer) that cannot be surgically removed and/or has spread to other parts of the body
  • Must agree to participate in additional research studies related to the main trial
  • Must not have received any previous treatment for advanced disease
  • Must have good physical function status (ECOG status of 0 or 1, meaning able to perform daily activities with minimal assistance)
  • Must have adequate blood test results, including:
    • Sufficient white blood cells, red blood cells, and platelets
    • Normal liver function tests
    • Normal kidney function
    • Normal blood clotting tests
    • Must have normal calcium and phosphate levels in blood
    • For patients who can have children:
      • Must use effective birth control during treatment and for specified time after treatment ends
      • Female patients must have a negative pregnancy test within 7 days before starting treatment
      • Male patients must not donate sperm during treatment and for a period after treatment

Who cannot join the trial?

14 criteria

  • Prior treatment with any cancer therapy for advanced colorectal cancer
  • Known allergies or severe reactions to the study medications (futibatinib, tislelizumab, or chemotherapy drugs)
  • Active or untreated brain tumors or cancer that has spread to the brain
  • Severe heart conditions including heart failure or uncontrolled high blood pressure
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • Significant liver problems (liver function tests more than 2.5 times above normal limits)
  • Significant kidney problems (creatinine clearance less than 30 mL/min)
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Major surgery within 4 weeks before starting the study
  • Participation in another clinical trial within 4 weeks before starting this study
  • Any medical condition that the doctor believes would make it unsafe to participate in the study
  • History of other cancers within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
  • Active autoimmune disease requiring systemic treatment
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Investigated drugs

Futibatinib is a targeted therapy medication that works by blocking specific proteins that contribute to cancer growth. It belongs to a class of drugs known as FGFR inhibitors, which can help stop the spread of certain types of cancer cells. Tislelizumab is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents the immune system from attacking cancer cells. By blocking PD-1, tislelizumab allows the immune system to better recognize and destroy cancer cells. Chemotherapy (specific agents not mentioned in the source data) is a traditional cancer treatment that uses drugs to kill rapidly dividing cells, including cancer cells. It may be given in combination with the other medications to provide a comprehensive treatment approach.

What is already known about the treatment

  • Futibatinib

    A novel targeted therapy drug administered orally that belongs to the class of FGFR inhibitors (fibroblast growth factor receptor inhibitors). This medication works by selectively blocking specific proteins involved in cancer cell growth and survival, particularly targeting the FGFR signaling pathway that is often dysregulated in various types of cancer. Currently undergoing clinical trials for colorectal cancer treatment, it is being studied in combination with immunotherapy (tislelizumab) and chemotherapy as a first-line treatment option.

  • Tislelizumab

    An innovative immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors (programmed cell death protein 1 inhibitors). This antibody-based treatment works by blocking the PD-1 pathway, helping to restore the immune system's ability to detect and fight cancer cells. Currently being investigated in clinical trials for colorectal cancer treatment in combination with futibatinib and chemotherapy, it represents a promising approach in cancer immunotherapy.

Investigated diseases

Colorectal cancer - A disease that begins when cells in the colon or rectum start growing out of control. It typically starts as small growths called polyps on the inner lining of the colon or rectum. Over time, some of these polyps can develop into cancer, growing into the wall of the colon or rectum. The disease usually develops slowly over several years. As the cancer grows, it can spread through the layers of the colon or rectal wall and eventually to other parts of the body. Early stages of the disease may not cause noticeable symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517573-24-00Protocol codeFUTUREEstimated enrolment33 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).