​​Perioperative zanidatamab combined with chemotherapy in HER2-positive locally advanced operable gastroesophageal adenocarcinoma (GEA): a Phase 1b/2a single-arm trial​

Condition studied

Gastroesophageal adenocarcinoma (GEA)

Investigational medicinal product(s)

Every trial of Zanidatamab and Tislelizumab across our registers →

Eligibility

Primary endpoint

Safety Incidence of qualifying safety events during the neoadjuvant period (first four cycles) in Phase 1b population as decision base for continuation of FLOT All other safety outcomes (including overall toxicity in Phases 1b and 2a) will be summarized descriptively., pCR improvement to 30% or higher in the 29 patients treated. The primary pCR analysis will be conducted in the overall treated population (N=29), acknowledging that chemotherapy backbone may differ due to the Phase 1b safety-triggered selection. Backbone regimen and exposure will be summarized, and a sensitivity analysis will descriptively report pCR by backbone (no formal hypothesis testing). The contribution of tislelizumab will be explored in the subset of patients receiving it.

Endpoint detail

EFS defined as the time from the first dose of IMP on study until the date of occurrence of any of the following events: Disease progression (per Response Evaluation Criteria in Solid Tumours [RECIST] 1.1) Clinical progression Failure to achieve complete resection Relapse Appearance of a new primary cancer Death from any cause Patients in whom no “event” is recorded at the time of discontinuation for other causes and starting a subsequent line of treatment will be censored for EFS, OS defined as the time from the first dose of IMP on study until death from any cause. Patients starting a subsequent line of treatment after study discontinuation will not be censored for survival at the start of this subsequent treatment. Subjects who are still alive at the time of final data cut-off date will be censored at the last day known to be alive.