Kurzfassung

Patients with advanced adenocarcinoma of the esophagus or stomach (GEJC) have an infamous prognosis after failure of first- and second-line chemotherapy. Often, these patients deteriorate rapidly. Second- or third-line chemotherapy has been established in selected patients, as three randomized trials have demonstrated a survival benefit of chemotherapy using taxanes (paclitaxel and docetaxel), irinotecan, or oral trifluridine/tipiracil (TAS 102) over best supportive care alone. A phase Ib...Patients with advanced adenocarcinoma of the esophagus or stomach (GEJC) have an infamous prognosis after failure of first- and second-line chemotherapy. Often, these patients deteriorate rapidly. Second- or third-line chemotherapy has been established in selected patients, as three randomized trials have demonstrated a survival benefit of chemotherapy using taxanes (paclitaxel and docetaxel), irinotecan, or oral trifluridine/tipiracil (TAS 102) over best supportive care alone. A phase Ib study recently demonstrated manageable toxicity and encouraging efficacy for patients with refractory advanced gastric cancer with the combination of the tyrosine kinase inhibitor regorafenib and the immunotherapy nivolumab (RegoNivo). The aim of this IITstudy, AIO-INTEGRATE-IIb study, is to compare the efficacy of RegoNivo in pre-treated GEJC patients with the current standard of care in a Phase III study. Another objective of the international INTEGRATE-IIb study is to investigate the difference in efficacy in different geographic regions: Australia, Asia, North America and Europe.
 
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