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A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

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

Record History

  1. Minor Study sites: 43 to 81v4
  2. Notable Primary completion date: Jun 30, 2024 to Dec 2026 Start date changed from estimate of May 1, 2020 to Aug 11, 2020 · Trial status: Not Yet Recruiting to Active, Not Recruiting · Completion date: Dec 31, 2024 to Dec 2026 · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of May 1, 2020 to Aug 11, 2020
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Completion date: Dec 31, 2024 to Dec 2026
    • Site contacts updated at 42 of 43 sites
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.
Trial Details
NCT Number NCT04344158
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Advanced Hepatocellular Carcinoma (HCC)
Enrollment 648 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov