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Metastatic Colorectal CancerPhase 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

A Phase 2 study testing Fruquintinib, Tislelizumab and Trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 23 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Fruquintinib, Tislelizumab and Trifluridine/tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
23 sitesin 2 countries
Study dates
27 Oct 2025to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient* provide signed informed consent form.
  • Patient is ≥ 18 years at the time of given informed consent.
  • Patient has been diagnosed with histologically or cytologically proven microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic adenocarcinoma of the colon or rectum, which is not amenable to potentially curative resection.
  • Known RAS (KRAS or NRAS) and BRAF V600E mutational status. Note: These mutations are mutually exclusive. Therefore, if one of the factors is mutated, it is not required to determine the mutation status of the others, as they are then assumed to be wildtype.
  • Patient without liver metastases (NLM) defined as subjects without active liver metastases at screening as determined on baseline imaging of the liver as performed by CT scan with contrast or MRI. Definitively treated liver metastases (which includes surgical resection, microwave or radiofrequency ablation, or stereotactic body radiation therapy, but not yttrium-90 or chemoembolization alone) that were treated at least 3 months prior to enrollment with no evidence of radiologic progression on subsequent imaging are considered to be non-active liver metastases.
  • Patient received at least one line of previous treatment with a fluoropyrimidine, oxaliplatin, irinotecan, VEGF(R) and if indicated EGFR and/or BRAF inhibitors in the advanced setting, or the patient has been intolerable or ineligible to those treatments.
Show all 19Show fewer
  • Patient has an ECOG performance status ≤ 1.
  • Patient has a life expectancy > 16 weeks.
  • Patient has adequate hematological, hepatic and renal function.
  • Absolute number of neutrophils (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (or < 2 x ULN in case of prior liver involvement or Gilbert's disease)
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN, AP ≤ 5 x ULN
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 30 mL/min (i.e., if serum creatinine level is > 1.5 x ULN, then a 24-hour urine test must be performed to check the creatinine clearance to be determined).
  • Urinary protein ≤2+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥3+, a 24-hour urine collection for protein must demonstrate <2000 mg of protein in 24 hours to allow participation in this protocol)
  • Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).
  • Female patients of childbearing potential or male patients in Arm B with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last trial treatment. Male patients in Arm B with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.
  • Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the trial gender-independently.

Who cannot join

  • Patient has known allergic / hypersensitive reactions to at least one of the treatment components
  • Patient had previous malignancy other than that under study within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer
  • Patient received previous treatment with Fruquintinib, trifluridine/tipiracil, regorafenib or an anti-PD-1/anti-PD-L1 antibodies.
  • Patient receives current treatment with any anti-cancer therapy, such as systemic immunotherapy, chemotherapy, or hormone therapy within ≤ 2 weeks prior to study treatment start.
  • Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy for symptom control).
  • Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
Show all 20Show fewer
  • Patient has impaired cardiac function or clinically significant cardiac disease including unstable angina within 6 months before the first dose of study treatment, acute myocardial infarction < 6 months prior to the first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure > 160 mmHg or diastolic > 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring antiarrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval (QTc) ≥ 470.
  • Patient has history of uncontrolled infection with human deficiency virus (HIV) or chronic infection with hepatitis B or C virus (HBV, HCV).
  • Patient has evidence of bleeding diathesis.
  • Patient has history of gastrointestinal perforation or fistulae in past 6 months or risk factors for perforation.
  • Patient has grade 3-4 gastrointestinal bleeding within 3 months prior to first dose of trial therapy.
  • Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug (see Appendix 4 for examples).
  • Patient had a major surgery within 2 weeks prior to first dose of trial therapy.
  • Patient experienced severe, life-threatening, or recurrent (Grade 2 or higher) immune-mediated adverse events (AEs) or infusion-related reactions including those that led to permanent discontinuation while on treatment with immune-oncology agents.
  • Patient received prior immunosuppressive therapy: immunosuppressive doses of systemic medications of > 10 mg/day of prednisone or equivalent must be discontinued ≥ 2 weeks before the first dose of study treatment. Short courses of high dose corticosteroids and/or continuous low dose of prednisone (< 10 mg/day) are permitted. In addition, inhaled, intranasal, intraocular, and/or joint injections of corticosteroids are allowed.
  • Patient has active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
  • Patient has history of solid organ transplantation .
  • Patient has history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or history of stroke and/or transient ischemic attack within the last 12 months.
  • Patients has evidence of any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
  • Female patient is pregnant or breast feeding or planning to become pregnant within and up to 6 months after end of treatment.

Trial locations and contacts

23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Alexander Stein, Prof. Dr. contact

+494036035220

stein@hope-hamburg.de

Martin Walker contact

+4969589978772

walker.martin@ikf-khnw.de

23 sites in 2 countries

Germany20 sites, 20 recruiting

  • Klinikum St. Marien Amberg

    Amberg

    Ludwig Fischer von Weikersthal, Dr.

    Recruiting

  • HELIOS Klinikum Bad Saarow

    Bad Saarow

    Daniel Pink, MD

    Daniel Pink, MD

    Recruiting

  • Charite Universitaetsmedizin Berlin KöR

    Berlin

    Arndt Stahler, PD Dr.

    Arndt Stahler, PD Dr.

    Recruiting

  • HELIOS Emil von Behring Berlin

    Berlin

    Börge Arndt, Dr.

    Börge Arndt, Dr.

    Recruiting

  • Katholisches Klinikum Bochum gGmbH

    Bochum

    Anke Reinacher-Schick, Prof. Dr.

    Anke Reinacher-Schick, Prof. Dr.

    Not yet recruiting

  • Universitätsklinikum Düsseldorf Klinik für Gastroenterologie, Hepatologie und Infektiologie Gastroonkologische Studienzentrale

    Düsseldorf, 40225

    Christoph Roderburg, Prof. Dr.

    Christoph Roderburg, Prof. Dr.

    Not yet recruiting

  • KEM | Klinik für Internistische Onkologie gGmbH

    Essen, 45136

    Christian Müller, Dr.

    Christian Müller, Dr.

    Recruiting

  • Universitätsklinikum Essen

    Essen, 45147

    Stefan Kasper, Prof. Dr.

    Stefan Kasper, Prof. Dr.

    Not yet recruiting

  • Goethe University Frankfurt

    Frankfurt

    Christine Koch, PD Dr.

    Christine Koch, PD Dr.

    Recruiting

  • Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest

    Frankfurt am Main, 60488

    Thorsten Götze, Prof.

    Thorsten Götze, Prof.

    Recruiting

  • Hamburg Hämatologisch-Onkologische Praxis Eppendorf-Facharztzentrum Eppendorf

    Hamburg, 20246

    Alexander Stein, Prof. Dr.

    Alexander Stein, Prof. Dr.

    Recruiting

  • Asklepios Kliniken Hamburg GmbH

    Hamburg

    Dirk Arnold, Prof. Dr.

    Dirk Arnold, Prof. Dr.

    Not yet recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Joseph Tintelnot, Dr.

    Joseph Tintelnot, Dr.

    Recruiting

  • Marienhospital Herne

    Herne

    Amin Turki, PD Dr.

    Amin Turki, PD Dr.

    Recruiting

  • Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, 76137

    Alexander Kolov, Dr.

    Alexander Kolov, Dr.

    Not yet recruiting

  • Klinikum der Universität München AöR

    München

    Sabrina Opatz, Dr.

    Sabrina Opatz, Dr.

    Recruiting

  • Klinikum rechts der Isar TU München

    München

    Sylvie Lorenzen, Prof. Dr.

    Sylvie Lorenzen, Prof. Dr.

    Recruiting

  • Leopoldina Krankenhaus Schweinfurt

    Schweinfurt

    Stephan Kanzler, Prof.

    Stephan Kanzler, Prof.

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier

    Ameen Aslan, Dr.

    Ameen Aslan, Dr.

    Not yet recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081

    Thomas Ettrich, Dr.

    Thomas Ettrich, Dr.

    Recruiting

Other trials in Germany

Austria3 sites, 3 recruiting

  • Ordensklinikum Linz GmbH

    Linz

    Bernhard Doleschal, Dr.

    Bernhard Doleschal, Dr.

    Not yet recruiting

  • SCRI CCCIT Ges.m.b.H.

    Salzburg

    Lukas Weiss, Prof. Dr.

    Lukas Weiss, Prof. Dr.

    Recruiting

  • Noe LGA Gesundheit Thermenregion GmbH

    Wiener Neustadt

    Birgit Grünberger, Prof. Dr.

    Birgit Grünberger, Prof. Dr.

    Not yet recruiting

Other trials in Austria

About this study

Official title: - 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

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.

Read the detailed description

Participants eligible for this trial will be randomized 1:1 into one of the two arms (Arm A and Arm B) stratified by: I) -Previous anti-angiogenic therapy (yes vs. no), II) BRAF/RAS mutation status (wildtype vs. mutation) or III) History of liver metastases (never vs. prior but treated).

Patients in Arm A (experimental arm) will receive Fruquintinib (orally, 5 mg once a day, at day 1-21 of each 28-day cycle [Q4W]) plus Tislelizumab (i.v., 400 mg, at day 1 of each 42-day cycle [Q6W]).

Patients in Arm B (control arm) will receive Trifluridine/tipiracil (orally, 35 mg/m2 twice a day, day 1-5 and day 8-12 of each 28-day cycle [Q4W]) plus Bevacizumab (i.v., 5 mg/kg, at day 1 of each 14-day cycle [Q2W]).

The treatment will be performed until disease progression, unacceptable toxicity, patients' request, or end of protocol-defined treatment time (maximum of 15 months).

All patients will be followed up for a maximum of 18 months after last patient in or until death, withdrawal of consent or loss to follow-up, whatever occurs first.

Being tested
Fruquintinib, Tislelizumab, Trifluridine/tipiracil, Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FruquintinibDrug

    Also called Fruzaqla

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

  • TislelizumabDrug

    Also called Tevimbra

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

  • Trifluridine/tipiracilDrug

    Also called Lonsurf

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

  • BevacizumabDrug

    Also called Avastin

    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)

Study groups in NCT06856837
Study groupRoleWhat they receive
Arm AExperimental* Fruquintinib (orally, 5 mg once a day, at day 1-21 of each 28-day cycle [Q4W]) plus * Tislelizumab (i.v., 400 mg, at day 1 of each 42-day cycle [Q6W])
Receives: Drug: Fruquintinib; Drug: Tislelizumab
Arm BActive comparator* Trifluridine/tipiracil (orally, 35 mg/m2 twice a day, day 1-5 and day 8-12 of each 28-day cycle [Q4W]) plus * Bevacizumab (i.v., 5 mg/kg, at day 1 of each 14-day cycle [Q2W])
Receives: Drug: Trifluridine/tipiracil; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of Fruquintinib in combination with the PD-1 inhibitor Tislelizumab in MSS/pMMR metastatic colorectal cancer without liver metastases.

    Progression-free survival (PFS), defined as time from randomization until date of progression acc. to RECIST v1.1 or death due to any cause.

    Measured: up to 54 month

Secondary outcomes (6)

  1. Overall survival

    Overall survival (OS), defined as time from randomization until date of death due to any cause.

    Measured: up to 54 month

  2. Objective response rate

    Objective response rate (ORR), defined as proportion of patients achieving complete or partial response (CR/PR) acc. to RECIST v1.1.

    Measured: up to 54 month

  3. Disease control rate

    Disease control rate (DCR), defined as proportion of patients achieving CR, PR, or stable disease (SD) acc. to RECIST v1.1.

    Measured: up to 54 month

  4. Duration of response

    Duration of response (DoR), defined as time from response initiation (when either CR or PR is first determined) to disease progression acc. to RECIST v1.1 or death due to any cause.

    Measured: up to 54 month

  5. To evaluate the safety and tolerability of Fruquintinib in combination with the PD-1 inhibitor Tislelizumab in MSS/pMMR metastatic colorectal cancer without liver metastases.

    Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing, and severity of adverse events using NCI CTCAE v5.0.

    Measured: up to 54 month

  6. To assess health-related quality of life (HRQoL) data of Fruquintinib in combination with the PD 1 inhibitor Tislelizumab in MSS/pMMR metastatic colorectal cancer without liver metastases.

    Assessment of HRQoL during treatment and follow-up using EORTC QLQ C30 and EQ-5D-5L questionnaires.

    Measured: up to 54 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start27 Oct 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants eligible for this trial will be randomized 1:1 into one of the two arms (experimental Arm A and control Arm B) stratified by: I) Previous anti-angiogenic therapy (yes vs. no), II) BRAF/RAS mutation status (wildtype vs. mutation), III) History of liver metastases (never vs. prior but treated)
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06856837
Sponsor's protocol ID
QUINTIS
Status last verified
Dec 2025
First submitted
18 Feb 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib, Tislelizumab and Trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Stein, Prof. Dr. (+494036035220, stein@hope-hamburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of Fruquintinib in combination with the PD-1 inhibitor Tislelizumab in MSS/pMMR metastatic colorectal cancer without liver metastases. (time frame: up to 54 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06856837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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