Fruquintinib and Chemotherapy for Metastatic Colorectal Cancer

This study is testing a new combination treatment for locally advanced unresectable or metastatic colorectal cancer. It combines standard chemotherapy (either FOLFIRI or mFOLFOX6, both containing 5-Fluorouracil or 5FU) with a drug called fruquintinib. The goal is to see how safe and effective this combination is as a first treatment. You might be able to join if you are 18 or older and have this type of colorectal cancer. The study will measure how long it takes for the cancer to progress while on this treatment, for up to 24 months. The study is currently recruiting 50 participants.

Study design
This is a Phase II interventional study, meaning all 50 participants will receive the study treatment. It is not specified if the study is blinded or randomized.
What's involved
You will receive treatment in 28-day cycles, with fruquintinib taken daily for 21 days of each cycle. Treatment continues until your disease progresses, you experience unacceptable side effects, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, time to progression, is assessed for up to 24 months from the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07042685

Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~50 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Fruquintinib Combined With Chemotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Progression of 5FU in combination with fruquintinib in first-line metastatic colorectal cancer patients
Measured over From date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 24 months.
Metastatic Colorectal Cancer (CRC)
1 sites across 1 states
Texas1
  • Maen Abdelrahim, MD, PhD, Pharm D · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
  • Abdullah Esmail, MD · STUDY_DIRECTOR · Houston Methodist Neal Cancer Center

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  • Time to Progression of 5FU in combination with fruquintinib in first-line metastatic colorectal cancer patientsFrom date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 24 months.

    To assess the time to progression (TTP) of patients with locally advanced unresectable or metastatic colorectal cancer (mCRC) treated with 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib, according to RECIST v1.1 criteria.