What is Fruquintinib studying for metastatic colorectal cancer?

Fruquintinib is being studied in combination with Tislelizumab to see how well it works for patients with microsatellite stable metastatic colorectal cancer without active liver metastases. This study aims to understand if this combination can improve treatment outcomes compared to other therapies. The trial is sponsored by the Institut für Klinische Krebsforschung IKF GmbH.

Who may be eligible for this metastatic colorectal cancer clinical trial?

Adults aged 18 and older with confirmed microsatellite stable or proficient mismatch repair metastatic colorectal cancer without active liver metastases may be eligible. This study includes all genders and requires prior treatment with certain chemotherapy drugs. Patients must also have good overall health and organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel or accommodations may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06856837

IKFAIO-QUINTIS Randomized Phase II Trial of Fruquintinib Plus Tislelizumab vs TrifluridineTipiracil Plus Bevacizumab in MSSpMMR 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

Research Sites

N/A

Total Duration

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 Trifluridinetipiracil 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

Age: 18Years +

All Genders

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.

Research Team

Alexander Stein, Prof. Dr.

Martin Walker

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