RecruitingPhase 2NCT06856837

- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases

- IKF/AIO-QUINTIS - A Randomized Phase II Trial Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

140 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer

Summary

This is a prospective, randomized, open-label, multicenter phase II investigating the therapy of Fruquintinib in combination with Tislelizumab in patients with MSS/pMMR metastatic colorectal cancer without liver metastases.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of fruquintinib (a targeted therapy that blocks tumor blood vessel growth) and tislelizumab (an immunotherapy drug) in patients with metastatic colorectal cancer that does not respond to immunotherapy on its own (MSS/pMMR type) and has no active liver metastases. **You may be eligible if...** - You are 18 or older with confirmed metastatic colorectal adenocarcinoma (MSS/pMMR) - Your cancer does not currently have active liver metastases - Your tumor's genetic mutation status (RAS and BRAF) is known - You have received prior lines of chemotherapy **You may NOT be eligible if...** - You have had prior treatment with fruquintinib, trifluridine/tipiracil, regorafenib, or any anti-PD-1/PD-L1 immunotherapy - You have active liver metastases - You have another cancer diagnosis within the past 3 years (except certain minor skin or cervical cancers) - You are currently receiving other anti-cancer therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib

highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3

DRUGTislelizumab

humanized immunoglobulin G4 (IgG4)-variant monoclonal antibody (mAb) against human programmed cell death-1 (PD-1)

DRUGTrifluridine/tipiracil

trifluridine, a nucleoside analog, and tipiracil, a thymidine phosphorylase inhibitor

DRUGBevacizumab

recombinant humanized anti-VEGF monoclonal antibody composed of human IgG1 framework regions and antigen-binding, complementarity-determining regions from a murine monoclonal antibody (muMAb VEGF A4.6.1)

Locations(23)

Ordensklinikum Linz GmbH

Linz, Austria

SCRI CCCIT Ges.m.b.H.

Salzburg, Austria

Noe LGA Gesundheit Thermenregion GmbH

Wiener Neustadt, Austria

Klinikum St. Marien Amberg

Amberg, Germany

HELIOS Klinikum Bad Saarow

Bad Saarow, Germany

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

HELIOS Emil von Behring Berlin

Berlin, Germany

Katholisches Klinikum Bochum gGmbH

Bochum, Germany

Universitätsklinikum Düsseldorf Klinik für Gastroenterologie, Hepatologie und Infektiologie Gastroonkologische Studienzentrale

Düsseldorf, Germany

KEM | Klinik für Internistische Onkologie gGmbH

Essen, Germany

Universitätsklinikum Essen

Essen, Germany

Goethe University Frankfurt

Frankfurt, Germany

Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest

Frankfurt am Main, Germany

Hamburg Hämatologisch-Onkologische Praxis Eppendorf-Facharztzentrum Eppendorf

Hamburg, Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Marienhospital Herne

Herne, Germany

Vincentius-Diakonissen-Kliniken gAG

Karlsruhe, Germany

Klinikum der Universität München AöR

München, Germany

Klinikum rechts der Isar TU München

München, Germany

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Germany

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, Germany

Universitätsklinikum Ulm

Ulm, Germany

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NCT06856837

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