FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)

StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 1, 2029 → Nov 1, 2029
See other at-risk trials from Sun Yat-sen University

Record History

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  1. Start date: Jun 1, 2026 to Nov 1, 2026 Show 4 more changesShow less
    • Primary completion pushed from Jun 1, 2029 to Nov 1, 2029
    • Study sites: 1 to 3
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Study First Submitted
  • 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.
This is a prospective, multicenter, randomized controlled, phase II study. It is expected to enroll 229 patients and aims to evaluate the efficacy and safety of FOLFOX8 versus mFOLFOX6 combined with bevacizumab or cetuximab as first-line treatment for unresectable metastatic colorectal cancer. The primary objective is to assess progression-free survival (PFS) of the patients. Secondary objectives include assessment of objective response rate (ORR), overall survival (OS), safety, and other outcomes.
Trial Details
NCT Number NCT07621497
Lead Sponsor Sun Yat-sen University
Conditions
(from sponsor)		 Metastatic Colorectal Cancer (CRC)
Related terms Colorectal Neoplasms
Enrollment 229 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov