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Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Not specified to Phase 4 Primary completion date: Feb 10, 2028 to Jul 1, 2029 · Start date: Oct 12, 2023 to Jul 1, 2024 · Trial status: Recruiting to Not Yet Recruiting · 7 morev6 Show 10 more changesShow less
    • Primary completion date: Feb 10, 2028 to Jul 1, 2029
    • Start date: Oct 12, 2023 to Jul 1, 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Enrollment target: 828 to 702
    • Completion date: Jun 30, 2028 to Nov 1, 2029
    • Interventions: Capecitabine (Drug), Huaier granule (Drug), Oxaliplatin (Drug), Tegafur, Gimeracil and Oteracil Potassium (Drug) to Huaier granule (Drug), Oxaliplatin (Drug), Tegafur, Gimeracil and Oteracil Potassium (Drug)
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 15, 2023 to Oct 12, 2023 · Study sites: 1 to 2v5 Show 2 more changesShow less
    • Start date changed from estimate of Jun 15, 2023 to Oct 12, 2023
    • Study sites: 1 to 2
  3. Interventions: Huaier granule (Drug), Oxaliplatin (Drug), Tegafur, Gimeracil and Oteracil Potassium (Drug) to Capecitabine (Drug), Huaier granule (Drug), Oxaliplatin (Drug), Tegafur, Gimeracil and Oteracil Potassium (Drug) Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 2 of 7 entries · Study description expanded, about 2 words · 1 morev4 Show 4 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description expanded, about 2 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Feb 10, 2023 to Jun 15, 2023v3
  5. Start date: Nov 30, 2022 to Feb 10, 2023 Primary completion date: Nov 30, 2027 to Feb 10, 2028 · Completion date: May 31, 2028 to Jun 30, 2028v2 Show 2 more changesShow less
    • Primary completion date: Nov 30, 2027 to Feb 10, 2028
    • Completion date: May 31, 2028 to Jun 30, 2028
  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 is a prospective, multi-center, open-label, randomised controlled study. The purpose of this study is to evaluate the efficacy and safety of Huaier Granule versus SOX regimen in the postoperative adjuvant treatment of resectable stage II-III gastric cancer.
Trial Details
NCT Number NCT05498766
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
Conditions Gastric Cancer
Enrollment 702 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov