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Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB

Study acronym: LIBImAb
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Study completion pushed from May 4, 2026 to Dec 2026
    • Site details revised at 4 of 4 sites
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date changed from estimate of Apr 29, 2023 to May 4, 2025
    • Study completion date: Apr 29, 2024 to May 4, 2026
    • Site details revised at 1 of 4 sites
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Apr 29, 2021 to Apr 30, 2021
    v3
  5. Interventions: Bevacizumab (Drug), Cetuximab (Drug) to 5-FU (Drug), Bevacizumab (Drug), Calcium levofolinate (Drug), Cetuximab (Drug), Irinotecan (Drug)v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS/BRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS/BRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.
Trial Details
NCT Number NCT04776655
Lead Sponsor Azienda USL Reggio Emilia - IRCCS
Collaborators: Istituto Di Ricerche Farmacologiche Mario Negri, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Conditions
(from sponsor)		 Colorectal Cancer, Metastatic Colorectal Cancer, RAS Mutation
Related terms Colorectal Neoplasms
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov