University of Wisconsin, Madison
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). Participants will be enrolled into one of four cohorts. Participants in Cohort 1 (HER-2 negative) will receive 5-FU, oxaliplatin and nal-IRI. Cohort 3 (HER-2 negative) will use nivolumab in addition to 5-FU, oxaliplatin and nal-IRI. Participants in Cohort 2 (HER-2 positive) will receive trastuzumab in a…
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. * Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS status prior to treatment initiation. * Measurable disease according to RECIST v1.1. * No prior lines of systemic therapy for advanced disease. * Participants who had recei…
chemotherapy drug
chemotherapy drug
chemotherapy drug
immunotherapy
immunotherapy
immunotherapy
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