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Study on Fruquintinib and Tislelizumab for Patients with Metastatic Colorectal Cancer Without Liver Metastases

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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 a type of cancer called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. The study specifically looks at cases without active liver metastases, meaning the cancer has not spread to the liver. The trial will test a combination of two treatments: Fruquintinib, a medication taken as a capsule, and Tislelizumab, a medication given through an intravenous infusion, which is a method of delivering medicine directly into the bloodstream. The purpose of the study is to evaluate how effective this combination is in treating this type of cancer.

Participants in the study will be randomly assigned to receive either the combination of Fruquintinib and Tislelizumab or other standard treatments. The study will monitor the participants over a period to see how the cancer responds to the treatment. This includes checking if the cancer stops growing or shrinks, and how long the participants live without the cancer getting worse. The study will also look at the safety of the treatment and any side effects that may occur.

The trial aims to provide more information on how well this combination of treatments works for patients with metastatic colorectal cancer without liver metastases. By participating, researchers hope to find better ways to manage and treat this type of cancer, potentially improving outcomes for future patients. The study will continue until enough data is collected to make a clear conclusion about the effectiveness and safety of the treatment combination.

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

    Joining the trial

    Upon joining the trial, you will be asked to provide a signed informed consent form. This document confirms your understanding of the trial and your willingness to participate.

    You will undergo a series of initial assessments to confirm your eligibility, including blood tests and imaging scans.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications. You will receive fruquintinib in the form of hard capsules, taken orally. The dosage and frequency will be determined by the study team.

    You will also receive tislelizumab through an intravenous infusion. This involves receiving the medication directly into your bloodstream through a vein.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the trial, you will continue to take the prescribed medications. Regular visits to the clinic will be scheduled to monitor your health and the effectiveness of the treatment.

    During these visits, you may undergo additional tests and assessments, such as blood tests and imaging scans, to track your progress.

  4. Step 4

    Follow-up assessments

    After completing the treatment phase, follow-up assessments will be conducted to evaluate your overall health and any long-term effects of the treatment.

    These assessments may include physical examinations, blood tests, and questionnaires about your quality of life.

  5. Step 5

    End of trial

    The trial concludes with a final evaluation of your health status. The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who can join the trial?

12 criteria

  • Patient must provide a signed informed consent form.
  • Patient must have adequate coagulation function, meaning their blood clots properly. This is measured by specific tests: International Normalized Ratio (INR) should be 1.5 or less, and partial thromboplastin time (PTT) should be no more than 5 seconds above the normal limit, unless they are on blood-thinning medication.
  • Female patients who can have children and male patients with female partners who can have children must agree to use effective birth control methods or avoid heterosexual intercourse during the study and for at least 6 months after the last treatment. Female patients must have a negative pregnancy test within 7 days before starting the trial.
  • Patient must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations.
  • Patient must be 18 years or older at the time of giving informed consent.
  • Patient must have been diagnosed with a specific type of colorectal cancer called microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic adenocarcinoma of the colon or rectum, which cannot be surgically removed to cure the disease.
  • Patient must know their RAS (KRAS or NRAS) and BRAF V600E mutational status. These are specific genetic markers related to the cancer.
  • Patient must not have active liver metastases, meaning the cancer has not spread to the liver, as confirmed by a CT scan or MRI. If the liver metastases were treated at least 3 months before joining the study and show no signs of growth, they are considered non-active.
  • Patient must have received at least one previous treatment involving specific cancer drugs, or they must have been unable to tolerate or be eligible for those treatments.
  • Patient must have an ECOG performance status of 1 or less. This is a scale that measures how well a patient can perform daily activities.
  • Patient must have a life expectancy of more than 16 weeks.
  • Patient must have adequate blood, liver, and kidney function, as measured by specific medical tests. This includes having enough white blood cells, platelets, and hemoglobin, as well as normal levels of bilirubin, liver enzymes, and creatinine.

Who cannot join the trial?

3 criteria

  • Patients with **liver metastases** cannot participate. Metastases are cancer cells that have spread from the original tumor to other parts of the body.
  • Patients who do not have **metastatic colorectal cancer** are excluded. Metastatic means the cancer has spread to other parts of the body.
  • Patients with a type of colorectal cancer that is not **MSS/pMMR** are excluded. MSS/pMMR refers to a specific genetic characteristic of the cancer.
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Investigated drugs

  • Fruquintinib

    is a medication that is being tested in this clinical trial. It is designed to help stop the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, Fruquintinib may help to slow down or stop the growth of cancer cells in the body. This medication is being studied to see if it can be effective in treating a specific type of colorectal cancer that has not spread to the liver.

  • Tislelizumab

    is another medication involved in this trial. It is a type of immunotherapy, which means it helps the body's immune system fight cancer. Tislelizumab works by blocking a protein that usually stops the immune system from attacking cancer cells. By blocking this protein, Tislelizumab may help the immune system to better recognize and destroy cancer cells. This trial is testing whether combining Tislelizumab with Fruquintinib can be more effective in treating certain colorectal cancers.

What is already known about the treatment

  • Fruquintinib

    Fruquintinib is taken orally and works by blocking certain proteins that help cancer cells grow, specifically targeting the blood vessels that supply the tumor. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer that has not spread to the liver. The main use of Fruquintinib is to help manage this type of cancer, especially when other treatments have not worked. It belongs to a group of drugs known as angiogenesis inhibitors, which aim to stop the growth of new blood vessels that tumors need to grow.

  • Tislelizumab

    Tislelizumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is being researched in clinical trials for its potential to treat metastatic colorectal cancer without liver metastases. This medication works by helping the immune system recognize and attack cancer cells more effectively. Tislelizumab is classified as a PD-1 inhibitor, a type of immunotherapy that blocks a pathway used by cancer cells to evade the immune system.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body. It typically progresses through the lymphatic system or bloodstream, reaching distant organs such as the lungs, bones, or peritoneum, but in this case, it does not involve the liver. The disease often begins with the formation of polyps in the colon or rectum, which can become cancerous over time. As the cancer cells grow and multiply, they invade surrounding tissues and can break away to form new tumors in other areas. The progression of metastatic colorectal cancer can vary, with some patients experiencing rapid spread while others may have a slower disease course. Symptoms may include changes in bowel habits, abdominal pain, weight loss, and fatigue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519929-38-00Protocol codeQUINTISEstimated enrolment140 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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