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

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 ID
NCT05713838
Phase
PHASE2
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Durvalumab
  • FLOT
  • mFOLFOX-6
  • Radiotherapy
Locations (sample)
  • Amberg, Germany|49.44287,11.86267
  • Bad Saarow, Germany|52.28333,14.06667
  • Berlin, Germany|52.52437,13.41053
  • Brandenburg an der Havel, Germany|52.41667,12.55
  • Bremen, Germany|53.07582,8.80717

Key Eligibility Criteria

  • Patient has given written informed consent.
  • Patient is, in the investigator's judgement, willing and able to comply with the study protocol including the planned surgical treatment.
  • Patient is ≥ 18 years of age at time of signing the written informed consent.
  • Patient has been diagnosed with histologically confirmed esophageal adenocarcinoma (including gastroesophageal junction (GEJ) (Siewert I-III)) with:

For full eligibility, visit ClinicalTrials.gov.

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