Clinical trial Recruiting at 3 sites Observational Ages 18 and up

Fruquintinib treatment in adults with metastatic colorectal cancer in Poland

Official title: FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients

Run by Takeda · NCT07623174 · Data updated 2026-11-12

This study looks at whether taking fruquintinib by mouth after prior therapies helps adults with metastatic colorectal cancer in Poland live longer before the cancer progresses and overall survival, while also considering quality of life.

More Metastatic Colorectal Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment110 (estimated)
SponsorTakeda
Industry-sponsored
Drugs / interventionsfruquintinib
Locations10 sites (Poznan, Greater Poland Voivodeship and 9 other locations)
StatusRecruiting
StartedAugust 13, 2026
Main results expectedMarch 31, 2028
Study endsMarch 31, 2028
Registry record updatedSeptember 22, 2026
Trial IDNCT07623174 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with metastatic colorectal cancer in Poland who are eligible for fruquintinib as a third-or-later-line treatment under the national program and can provide informed consent.

Probably not a fit

Patients who do not experience disease control or who discontinue due to progression or intolerable toxicity may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study conducted in Poland to assess outcomes of fruquintinib in adults with metastatic colorectal cancer after at least two prior treatments. The primary end point is progression-free survival, with overall survival as a key secondary measure and attention to patient quality of life. There are no active interventional procedures beyond the standard drug program; data will be collected from medical records and patient consent. Enrollment is limited to patients who qualify under the national drug program and who provide informed consent. The study aims to characterize real-world effectiveness and safety in a routine clinical setting across multiple Polish centers.

Why it matters

Potential benefit: Participants may experience disease control and potential survival benefit from fruquintinib, along with better understanding of its real-world impact on quality of life.

How similar studies have gone: Prior studies of fruquintinib in similar settings have shown potential benefits in progression-free and overall survival in metastatic colorectal cancer, supporting real-world investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride/tipiracil.
2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.
3. Participants for whom adequate medical records are available to support the data collection requirements.

Exclusion Criteria:

1\. Participant currently participates or plans to participate in an interventional clinical trial.

Where it's running

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie, Klinika Chorob Metabolicznych i Immunoonkologii, Oddzial Onkologii Klinicznej
    Lublin, Lublin Voivodeship, Poland
    Recruiting
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu, Oddzial Onkologiczny z Pod. Dziennej Chemioterapii
    Przemyśl, Podkarpackie Voivodeship, Poland
    Recruiting
  • Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku, Oddzial Onkologii Klinicznej im. dr E. Pileckiej z pododdzialem Chemioterapii Dziennej
    Bialystok, Podlaskie Voivodeship, Poland
    Recruiting
  • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej Curie, Oddzial Onkologii Klinicznej i Immunoonkologii z Pododdzialem Dziennym i Izb Przyjec
    Poznan, Greater Poland Voivodeship, Poland
    Not yet recruiting
  • Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy, Ambulatorium Chemoterapii
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
    Not yet recruiting
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Onkologii
    Krakow, Lesser Poland Voivodeship, Poland
    Not yet recruiting
Show 4 more locations
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Onkologii i Radioterapii
    Warsaw, Masovian Voivodeship, Poland
    Not yet recruiting
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu, Klinika Onkologii, Odcinek Dzienny
    Opole, Opole Voivodeship, Poland
    Not yet recruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
    Gliwice, Slskie, Poland
    Not yet recruiting
  • Zachodniopomorskie Centrum Onkologii, Oddzial Onkologii Klinicznej
    Szczecin, West Pomeranian Voivodeship, Poland
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.