Actively Recruiting
- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-12-12
140
Participants Needed
23
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older at consent.
- Histologically or cytologically confirmed MSS/pMMR metastatic adenocarcinoma of colon or rectum not suitable for curative surgery.
- Known RAS (KRAS or NRAS) and BRAF V600E mutation status.
- No active liver metastases; previously treated liver metastases must be at least 3 months prior with no progression.
- Received at least one prior line of treatment including fluoropyrimidine, oxaliplatin, irinotecan, VEGF(R), and if applicable EGFR and/or BRAF inhibitors, or intolerant/ineligible to these treatments.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 16 weeks.
- Adequate blood counts, liver, and kidney function as defined in protocol.
- Adequate coagulation function (INR ≤ 1.5, PTT ≤ 5 seconds above ULN unless on anticoagulation).
- Female patients of childbearing potential and male patients with female partners of childbearing potential agree to use effective contraception or abstinence during treatment and for 6 months after.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment.
- Willing and able to comply with study protocol, treatments, visits, and follow-up.
You will not qualify if you...
- Known allergy or hypersensitivity to any treatment components.
- Previous malignancy within 3 years except certain low-risk cancers.
- Prior treatment with Fruquintinib, trifluridine/tipiracil, regorafenib, or anti-PD-1/PD-L1 antibodies.
- Anti-cancer therapy within 2 weeks prior to study start.
- Concurrent anti-cancer therapies other than study treatments (excluding palliative radiotherapy).
- Untreated or symptomatic central nervous system or leptomeningeal metastases.
- Significant cardiac disease or unstable angina within 6 months before treatment.
- History of uncontrolled HIV, hepatitis B or C infections.
- Bleeding disorders.
- Recent gastrointestinal perforation, fistulae, or bleeding.
- Use of strong CYP3A4 inducers or inhibitors within 2 weeks before treatment.
- Major surgery within 2 weeks prior to treatment.
- Severe immune-related adverse events or infusion reactions from prior immunotherapy.
- Recent use of high-dose immunosuppressive therapy.
- Active autoimmune disease requiring systemic treatment within past 2 years.
- History of solid organ transplantation.
- Recent thromboembolic events or stroke.
- Any other serious medical condition posing high risk or reducing treatment effectiveness.
- Pregnancy, breastfeeding, or planning pregnancy during and up to 6 months after treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Ordensklinikum Linz GmbH
Linz, Austria
Not Yet Recruiting
2
SCRI CCCIT Ges.m.b.H.
Salzburg, Austria
Actively Recruiting
3
Noe LGA Gesundheit Thermenregion GmbH
Wiener Neustadt, Austria
Not Yet Recruiting
4
Klinikum St. Marien Amberg
Amberg, Germany
Actively Recruiting
5
HELIOS Klinikum Bad Saarow
Bad Saarow, Germany
Actively Recruiting
6
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Actively Recruiting
7
HELIOS Emil von Behring Berlin
Berlin, Germany
Actively Recruiting
8
Katholisches Klinikum Bochum gGmbH
Bochum, Germany
Not Yet Recruiting
9
Universitätsklinikum Düsseldorf Klinik für Gastroenterologie, Hepatologie und Infektiologie Gastroonkologische Studienzentrale
Düsseldorf, Germany, 40225
Not Yet Recruiting
10
KEM | Klinik für Internistische Onkologie gGmbH
Essen, Germany, 45136
Actively Recruiting
11
Universitätsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
12
Goethe University Frankfurt
Frankfurt, Germany
Actively Recruiting
13
Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
Actively Recruiting
14
Hamburg Hämatologisch-Onkologische Praxis Eppendorf-Facharztzentrum Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
15
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
Not Yet Recruiting
16
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
17
Marienhospital Herne
Herne, Germany
Actively Recruiting
18
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, Germany, 76137
Not Yet Recruiting
19
Klinikum der Universität München AöR
München, Germany
Actively Recruiting
20
Klinikum rechts der Isar TU München
München, Germany
Actively Recruiting
21
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, Germany
Actively Recruiting
22
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, Germany
Not Yet Recruiting
23
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
A
Alexander Stein, Prof. Dr.
CONTACT
M
Martin Walker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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