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Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 2025 → Jan 1, 2027
See other at-risk trials from Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2025 to Jan 1, 2027
    • Enrollment closed, study ongoing
    • Site details revised at 22 of 22 sites
    v7
  2. Primary completion date: Aug 2024 to Dec 2025
    • Study sites: 16 to 22
    • Study completion date: Feb 2027 to Dec 2028
    • Eligibility criteria expanded, about 84 words
    v6
  3. Site details revised at 4 of 16 sitesv5
  4. Study sites: 6 to 16
    • Start date changed from estimate of Aug 2023 to Aug 28, 2023
    v4
  5. Start date: Jul 2023 to Aug 2023v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2023 to Jul 2023
    • Study sites: 1 to 6
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial investigating whether a definite organ preservation therapy consisting of the combination of durvalumab with chemoradiation is an efficient and safe treatment option for early stage, cT1 and cT2N0, esophageal adenocarcinoma with indication for radical surgery.
Trial Details
NCT Number NCT05713838
Lead Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions
(from sponsor)		 Esophagus Adenocarcinoma
Related terms Adenocarcinoma Of Esophagus
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov