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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | fruquintinib |
| Locations | 10 sites (Poznan, Greater Poland Voivodeship and 9 other locations) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07623174 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
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating a new treatment for advanced colorectal cancer
This study is testing a new combination treatment for advanced colorectal cancer to see if it can help patients who haven't had success with other therapies.
-
Fruquintinib plus tislelizumab versus trifluridine/tipiracil plus bevacizumab for MSS/pMMR metastatic colorectal cancer without active liver metastases
This trial tests whether combining fruquintinib with tislelizumab works better than trifluridine/tipiracil plus bevacizumab for adults with MSS/pMMR metastatic colorectal cancer who do not have active liver metastases.
-
Candonilimab with Fruquintinib and Paclitaxel Albumin-Bound as second-line treatment for advanced gastric cancer
This phase 2 trial tests whether adding candonilimab to fruquintinib and nab-paclitaxel helps people with advanced gastric or gastroesophageal junction cancer who progressed after first-line therapy.
-
Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies
This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.
-
Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX
This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.
-
Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer
This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.