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A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Jan 1, 2026 to Jan 12, 2026 Interventions: CAPOX (oxaliplatin/capecitabine) (Drug), Disitamab Vedotin (Drug), Pembrolizumab (Drug), Tislelizumab (Drug), Trastuzumab (Drug) to CAPOX (oxaliplatin/capecitabine) (Drug), Disitamab Vedotin (Drug), Pembrolizumab (Drug), Tislelizumab (Drug), Trastuzumab (Drug) · Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 4 of 9 entries Show 3 more changesShow less
    • Interventions: CAPOX (oxaliplatin/capecitabine) (Drug), Disitamab Vedotin (Drug), Pembrolizumab (Drug), Tislelizumab (Drug), Trastuzumab (Drug) to CAPOX (oxaliplatin/capecitabine) (Drug), Disitamab Vedotin (Drug), Pembrolizumab (Drug), Tislelizumab (Drug), Trastuzumab (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 9 entries
  2. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
Trial Details
NCT Number NCT07315750
Lead Sponsor RemeGen Co., Ltd.
Conditions Gastric Carcinoma
Enrollment 555 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov