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A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Aug 2025 to Jul 30, 2027v2 Show 8 more changesShow less
    • Start date: Jan 2025 to Jul 30, 2025
    • Trial status: Recruiting to Not Yet Recruiting
    • Enrollment target: 82 to 100
    • Study completion date: Aug 2026 to Jul 30, 2028
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 103 words
    • Site details revised
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.
Trial Details
NCT Number NCT06772233
Lead Sponsor Peking University
Conditions
(from sponsor)		 Metastatic Gastrointestinal Stromal Tumors (GIST)
Related terms Gastrointestinal Stromal Tumors
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov