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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH Schweinfurt Germany
Klinikum St Marien Amberg Amberg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie Hamburg Germany
Udosniutxjzzxszyyhwuy Dspjlcmtmtq Awp Duesseldorf Germany
Kxokxlnx Eknxmlmvrqvrmxcfbrystbyk Hnwuejyiskxjxcvzs Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.07.2025

Trial locations

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.

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 ID:
2024-517573-24-00
Protocol code:
FUTURE
NCT ID:
NCT06722183
Trial Phase:
Therapeutic exploratory (Phase II)

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