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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
HELIOS Klinikum Bad Saarow GmbH	Bad Saarow	Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH	Trier	Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt	Germany
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Klinikum St Marien Amberg	Amberg	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Vincentius-Diakonissen-Kliniken gAG	Karlsruhe	Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Studienzentrum Onkologie Ravensburg GmbH	Ravensburg	Germany
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
St. Josefs-Hospital Wiesbaden GmbH	Wiesbaden	Germany
Norddeutsches Studienzentrum fuer Innovative Onkologie- Haematologisch-Onkologische Praxis Eppendorf	Hamburg	Germany
Universitätsmedizin Halle	Halle (Saale)	Germany
Universitätsklinikum Leipzig AöR	Leipzig	Germany
Nbt Ljz Glujawiuux Tkgujqgxbzpbx Gftk	Wiener Neustadt	Austria
Ubgunrkisj Mzgxpyk Cwqlcv Hyliflkwlgddlkeaz	Hamburg	Germany
Utjqwgpueejyvtttljumg Efcql Azf	Essen	Germany
Oymbzeuqxoaxbq Lkbs Gtvr	Linz	Austria
Ufutjvaoipoevwmmbafyd Ayijslhr	Augsburg	Germany
Uzlclpinzmltkpbepabpn Dbvkpxapxtl Aja	Duesseldorf	Germany
Gznwnb Ugfguibawl Fwaanekzq	Frankfurt	Germany
Kzkfimtd dmr Utlmbynhiiaa Mcqbinor Axs	Munich	Germany
Kyhxgint Extwuvscldmbeskuksugdwum Htgfkgvsotwyrggkc	Essen	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.04.2025
Germany	Recruiting	01.04.2025

Trial locations

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.

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 ID:

2024-519929-38-00

Protocol code:

QUINTIS

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?