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Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study

Study acronym: SANO-3
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Apr 2025 to Oct 2026 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 74 to confirmed 77 · Site details revisedv5 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 74 to confirmed 77
    • Site details revised
  2. Eligibility criteria expanded, about 2 wordsv4 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Apr 2026 to Apr 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2022 to Sep 29, 2022 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2022 to Sep 29, 2022
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In an effort to prevent surgery in selected patients with esophageal cancer, the SANO-2 study offers active surveillance to patients with clinically complete response (cCR) after neoadjuvant chemoradiation (nCRT). Some of these patients will never develop locoregional and/or distant recurrence of disease (persistent cCR). However, two-thirds of the patients that undergo active surveillance still get disease recurrence. This can be locoregional regrowth or distant metastases. To increase the efficacy of active surveillance (reduce the proportion of patients that need surgery) and improve survival, effective systemic maintenance therapy is needed. The CheckMate 577 randomized, placebo controlled, clinical trial showed that Nivolumab increases disease free survival in patients after nCRT and esophagectomy. Objective: To assess the efficacy of nivolumab during active surveillance in patients with cCR after neoadjuvant chemoradiation for esophageal cancer
Trial Details
NCT Number NCT05491616
Lead Sponsor Erasmus Medical Center
Conditions Esophageal Cancer
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov