Neoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in non-metastatic, resectable gastric and GE-junction cancer - de PANDA trial

Primary resectable, histologically confirmed gastric or gastro-esophageal junction adenocarcinoma

Safety, measured by SAEs and treatment related complications leading to delays in systemic treatment and/or surgery

Pathological tumor regression grade and the rate of complete and near-complete response, measured using the Mandard tumor regression grading system, Effect of therapy on intratumoral T-cell infiltration, CD4/CD8 ratio and immune checkpoints upregulation in the time interval post-atezolizumab monotherapy, post combination treatment with chemotherapy and at surgery, Correlation of pre-treatment T-cell infiltration and pathological response, Radiological tumor regression, and when possible the (immune) recist criteria, will be assessed prior to cycle 4 of combination treatment, Immunogenic mutational load as determined by tumor tissue DNA WES (with peripheral blood DNA WES as a control for somatic mutation sorting) and correlated to response (only genes relating to gastric cancer and/or immune-related genes, deemed informational for this study, will be assessed), Immune suppressive pathways and IFN-y induced gene expression will be analyzed by use of RNA sequencing on pre- and post-therapy tissue. Baseline immune gene signatures will be assessed for their predictive value of response to treatment, For a limited amount of patients, changes in the tissue and peripheral blood TCR repertoire and clonality will be determined, Date of relapse, as determined by disease recurrence or disease-related death during followup after surgery. Follow-up will be performed according to the assessment table, When enough material is available, organoids cultured from both normal and tumor tissue preand post-therapy will be grown and stored

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