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First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 4 of 20 sites
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 19 to 20
    • Start date changed from estimate of Dec 10, 2024 to Oct 17, 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
Trial Details
NCT Number NCT06730373
Lead Sponsor Qilu Hospital of Shandong University
Conditions
(from sponsor)		 HER2-positive Gastric Cancer, Metastatic Gastric Cancer, Unresectable Gastric Carcinoma
Related terms Stomach Neoplasms
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov