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A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

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

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 360 to confirmed 453 · Site details revisedv4 Show 2 more changesShow less
    • Enrollment target: estimated 360 to confirmed 453
    • Site details revised
  2. Phase: Phase 1 to Phase 3 Enrollment target: 100 to 360 · Primary endpoints: 1 to 2 · Interventions: IBI310 (Drug), Radical surgery (Procedure), Sintilimab (Drug) to IBI310&Sintilimab (Drug), Radical surgery (Procedure), Sintilimab (Drug) · 2 morev3 Show 5 more changesShow less
    • Enrollment target: 100 to 360
    • Primary endpoints: 1 to 2
    • Interventions: IBI310 (Drug), Radical surgery (Procedure), Sintilimab (Drug) to IBI310&Sintilimab (Drug), Radical surgery (Procedure), Sintilimab (Drug)
    • Secondary endpoints: 3 to 2
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 9, 2023 to May 25, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jun 9, 2023 to May 25, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Trial Details
NCT Number NCT05890742
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions MSI-H
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov