Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
Assessment of Metabolic and Pathological Response to Treatment With RCT and ImT Before Surgery in Locally Advanced Esophageal and Gastro-esophageal Junction Cancer: ARTemIS-Eso, a Three-level, Open-label, Phase I-II Study
ARTemIS-Eso is a phase I-II, three-level, open-label trial with a dose-expansion cohort at recommended schedule in both esophageal cancer histological groups (squamous cell carcinoma and adenocarcinoma) of RCT and ImT administered prior to surgery.
This study is indicated to patients with adenocarcinomas of the esophagus or
gastro-esophageal junction and squamous cell carcinoma of the esophagus.
The study consists of 2 parts:
Phase I of the study is composed of the 3 following levels, corresponding to changes in the
schedule and the number of administrations of monalizumab:
Level 1: monalizumab (ImT) administration starts 2 weeks after the end of RCT (Total of 3 ImT
doses). A maximum of 7 days delay is allowed.
Level 2: monalizumab administration starts directly at the end of RCT (Total of 4 ImT doses).
The first dose of monalizumab should be given on the following working day after the last
radiotherapy administration.
Level 3: monalizumab administration starts 2 weeks after the start of RCT (total of 6 ImT
doses). A maximum of 7 days delay is allowed.
Phase II (Expansion cohort): At the recommended level determined in phase I and according to
the number of patients already accrued, approximately 48-51 additional patients (half-SCC and
half-ADC) are included with the aim of assessing the activity of the recommended combination.
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