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A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jul 30, 2020 to May 27, 2021 Completion date: Dec 31, 2025 to Dec 2026v4 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 2026
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 698 to confirmed 748 · Study sites: 5 to 92 · Completion date: Dec 31, 2024 to Dec 31, 2025 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: estimated 698 to confirmed 748
    • Study sites: 5 to 92
    • Completion date: Dec 31, 2024 to Dec 31, 2025
    • Start date: May 27, 2021 to Jul 30, 2020
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 1, 2021 to May 27, 2021 · Site details revised at 5 of 5 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2021 to May 27, 2021
    • Site details revised at 5 of 5 sites
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open label, randomized, phase Ⅲ study to treat subjects with RAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into two arms consist of Anlotinib (3 weeks/cycle) + CapeOx and Bevacizumab (3 week/cycle) + CapeOx at a ratio of 1:1. This study is conducted to assess the efficacy and safety of Anlotinib and Chemotherapy as first-line treatment in subjects with RAS/BRAF wild-type Metastatic Colorectal Cancer.
Trial Details
NCT Number NCT04854668
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Metastatic Colorectal Cancer
Enrollment 748 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov