Actively Recruiting
IKF/AIO-QUINTIS: Randomized Phase II Trial of Fruquintinib Plus Tislelizumab vs Trifluridine/Tipiracil Plus Bevacizumab in 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates treatment options for patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) metastatic colorectal cancer who do not have active liver metastases. It is a phase II, prospective, randomized, open-label study conducted across multiple centers. The study aims to evaluate the effectiveness of Fruquintinib combined with Tislelizumab compared to a control treatment in this specific patient group. Participants will be randomly assigned to one of two groups. One group will receive Fruquintinib orally once daily for 21 days in a 28-day cycle along with Tislelizumab given intravenously every 42 days. The other group will receive Trifluridine/tipiracil orally twice daily on specific days of a 28-day cycle plus Bevacizumab intravenously every 14 days. Treatment will continue until disease progression, unacceptable side effects, patient choice, or a maximum of 15 months. During the study, patients will undergo regular assessments including imaging scans to monitor disease status, evaluations of side effects, and quality of life measures. Follow-up will continue for up to 18 months after the last patient begins treatment or until death, withdrawal, or loss to follow-up. Researchers will primarily measure the efficacy of the Fruquintinib and Tislelizumab combination, along with overall survival, response rates, safety, and quality of life.
CONDITIONS
Brief 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...
- Patient provides signed informed consent form.
- Patient is 18 years or older at the time of consent.
- Diagnosed with histologically or cytologically confirmed MSS/pMMR metastatic adenocarcinoma of the colon or rectum not suitable for curative surgery.
- Known RAS (KRAS or NRAS) and BRAF V600E mutation status.
- No active liver metastases at screening; previously treated liver metastases must be at least 3 months prior and stable.
- Received at least one prior treatment line including fluoropyrimidine, oxaliplatin, irinotecan, VEGF(R) inhibitors, and if applicable EGFR or BRAF inhibitors, or are intolerant/ineligible for these.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 16 weeks.
- Adequate blood counts, liver, kidney, and coagulation function as defined.
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use effective contraception or abstain during treatment and for 6 months after.
- Willing and able to comply with study protocol and visits.
You will not qualify if you...
- Known allergic or hypersensitive reactions 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.
- Current anti-cancer therapy within 2 weeks before study treatment.
- Receiving other anti-cancer therapies outside the trial protocol.
- Untreated or symptomatic central nervous system or leptomeningeal metastases.
- Significant cardiac disease or impaired heart function.
- Uncontrolled infections including HIV, hepatitis B or C.
- Evidence of bleeding disorders.
- Recent gastrointestinal perforation, fistulae, or serious bleeding.
- Use of strong CYP3A4 inducers or inhibitors within 2 weeks before treatment.
- Major surgery within 2 weeks before treatment.
- Severe immune-related adverse events from prior immunotherapy.
- Recent high-dose immunosuppressive therapy.
- Active autoimmune disease requiring systemic treatment in last 2 years.
- History of solid organ transplantation.
- Recent thromboembolic events or stroke.
- Other serious medical conditions increasing risk or reducing treatment effect.
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 months
Participants receive assigned drug combinations as treatment until disease progression, unacceptable toxicity, patient request, or maximum treatment time of 15 months.
Multiple visits according to treatment schedules: Fruquintinib daily for 21 days every 28-day cycle, Tislelizumab every 42 days, Trifluridine/tipiracil on days 1-5 and 8-12 every 28-day cycle, Bevacizumab every 14 days
Duration - Up to 18 months
Participants are followed up for safety and survival for up to 18 months after last treatment or until death, withdrawal, or loss to follow-up.
Visits scheduled periodically during follow-up
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.
M
Martin Walker
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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