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Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Interventions: FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line) + BEVACIZUMAB (Drug), FOLFOX (if FOLFIRI in first line) OR FOLFIRI… to 5 FU bolus (Drug), 5 FU continuous (Drug), BEVACIZUMAB (Drug), FRUQUINTINIB (Drug), Folinic acid (Drug), Irinotecan (Drug), Oxaliplatin…
    • Study title shortened, about 8 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.
Trial Details
NCT Number NCT07150403
Lead Sponsor Federation Francophone de Cancerologie Digestive
Conditions
(from sponsor)		 Metastatic Colorectal Carcinoma (mCRC)
Related terms Colorectal Neoplasms
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov