Evaluating Fruquintinib for Metastatic Colorectal Cancer

Is this trial a fit for you?

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

What this trial studies

This observational study, known as FRUQUENT, is being conducted in Germany to assess the effectiveness of Fruquintinib in patients with metastatic colorectal cancer (mCRC) who have previously undergone standard therapies. The study will collect real-world data on patient responses to Fruquintinib, including survival rates, safety, healthcare utilization, and quality of life. It aims to enroll 150 patients across 50 clinical practices, allowing for a comprehensive evaluation of treatment outcomes in routine clinical settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18 years or older.
* Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
* Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
* Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
* Other criteria according to current SmPC.
* Signed written informed consent.\* \* Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.

Exclusion Criteria:

* Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
* Contraindications according to current SmPC.

Where it's running

• Hämatologikum Biberach
  Biberach, Baden-Wurttemberg, Germany Recruiting
• Praxis für interdisziplinäre Onkologie & Hämatologie
  Freiburg im Breisgau, Baden-Wurttemberg, Germany Recruiting
• Onkologische Schwerpunktpraxis
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
  Ravensburg, Baden-Wurttemberg, Germany Recruiting
• Zentrum Ambulante Onkologie
  Schorndorf, Baden-Wurttemberg, Germany Recruiting
• ze:ro Praxen MVZ für Innere Medizin Weinheim
  Weinheim, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Principal investigator: Professor Dr. med. Sebastian Stintzing — Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie
• Study coordinator: Max D Mai, MSc
• Email: fruquent@iomedico.com
• Phone: +49 761 152420

Similar studies

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

• 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.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07920224

• 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.

  Recruiting Phase 2 Renmin Hospital of Wuhan University · Wuhan, Hubei · NCT07896096

• 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.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Fruquintinib plus anti-EGFR antibody for third-line metastatic colorectal cancer

  This study tests whether adding fruquintinib to cetuximab-beta helps adults with RAS wild-type metastatic colorectal cancer who have already tried and not benefited from at least two prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07724223

• Fruquintinib treatment in adults with metastatic colorectal cancer in Poland

  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.

  Recruiting at 3 sites Takeda · Poznan, Greater Poland Voivodeship and 9 other locations · NCT07623174

• Oral Paclitaxel Plus Fruquintinib as Second-Line Treatment in Advanced Gastric/GEJ Cancer

  This trial tests whether taking an oral paclitaxel solution together with fruquintinib, chosen by the investigator, can help adults with advanced or metastatic stomach or gastroesophageal junction cancer after first-line therapy.

  Recruiting at 15 sites Harbin Medical University · Fuzhou, Fujian and 14 other locations · NCT07552402

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.