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A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 130 to 201 Primary completion date changed from estimate of Jul 10, 2024 to Jul 10, 2025 · Primary endpoint revised · Trial status: Recruiting to Active, Not Recruiting · 7 morev4 Show 10 more changesShow less
    • Primary completion date changed from estimate of Jul 10, 2024 to Jul 10, 2025
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jul 10, 2025 to Oct 10, 2026
    • Interventions: Capecitabine (Drug), Oxaliplatin injection (Drug), RC48-ADC (Drug), Toripalimab (Drug), Trastuzumab Injection (Drug) to Capecitabine（1000mg/m2） (Drug), Capecitabine（750mg/m2） (Drug), Oxaliplatin（100mg/m2 ） (Drug), Oxaliplatin（130mg/m2 ） (Drug)…
    • Secondary endpoints revised (5)
    • Study description shortened, about 62 words
    • Site details revised
    • Study arms: 5 to 8
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 60 to 130 Primary endpoint revised · Interventions: Capecitabine (Drug), Herceptin (Drug), Oxaliplatin injection (Drug), RC48-ADC (Drug), Toripalimab (Drug) to Capecitabine (Drug), Oxaliplatin injection (Drug), RC48-ADC (Drug), Toripalimab (Drug), Trastuzumab Injection (Drug) · Secondary endpoints: 4 to 5 · 2 morev3 Show 5 more changesShow less
    • Primary endpoint revised
    • Interventions: Capecitabine (Drug), Herceptin (Drug), Oxaliplatin injection (Drug), RC48-ADC (Drug), Toripalimab (Drug) to Capecitabine (Drug), Oxaliplatin injection (Drug), RC48-ADC (Drug), Toripalimab (Drug), Trastuzumab Injection (Drug)
    • Secondary endpoints: 4 to 5
    • Study description revised
    • Study arms: 3 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 30, 2023 to Aug 4, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Aug 30, 2023 to Aug 4, 2023
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
Trial Details
NCT Number NCT05980481
Lead Sponsor RemeGen Co., Ltd.
Conditions Gastric Cancer
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov