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A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC

StatusRecruiting
PhasePhase 3
Started2011-11-14
View on ClinicalTrials.gov ↗

Amendment history

2026-06-03
minor
Study Status, Sponsor/Collaborators, Study Description, Outcome Measures v1
Primary completion date2017-12-31→2026-12-31
Completion date2018-12-31→2026-12-31
Secondary endpoints5 entries, revised
Progression-freeOverall survival (PFS)
Primary endpoints1 entry, revised
OverallProgression-free survival (PFS)
Study description+1 characters
Primary endpoint: Overall survival (OS), Secondary endpoints: Progression-free survival (PFS); Secondary endpoints: Overall survival (OS), Time to treatment failure (TTF), Overall response rate (ORR), Disease Control Rate (DCR), Safety.
2017-10-02
minor
Original filing
The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Trial Details
NCT Number NCT03303495
Lead Sponsor Sun Yat-sen University
Conditions Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
Enrollment 280 participants
Start Date 2011-11-14
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-05