HER2-positive, localized esophagogastric adenocarcinoma
Conditions
Brief summary
disease-free survival and the pathological complete response rate (co-primary)
Detailed description
ORR – percentage of patients with CR or partial response (PR) according to RECIST 1.1., R0 resection - microscopically margin negative resection with no gross or microscopic tumor remains in the areas of the primary tumor and/or sampled regional lymph nodes., OS – time from enrolment to the date of death of any cause Feasibility rate - severe toxicity/withdrawal rate before the last postoperative administration of pembrolizumab/trastuzumab/FLOT has been completed., (Serious) adverse events - recorded and graded according to NCI-CTCAE V5.0. Occurrence of (serious) adverse events at any time during the study. Description by nature (System Organ Class and Preferred Term), severity and causal relationship to drug administration.
Interventions
DRUGOntruzant 420 mg powder for concentrate for solution for infusion
DRUGOxaliplatin onkovis 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGInjektionslösung
Sponsors
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival and the pathological complete response rate (co-primary) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR – percentage of patients with CR or partial response (PR) according to RECIST 1.1., R0 resection - microscopically margin negative resection with no gross or microscopic tumor remains in the areas of the primary tumor and/or sampled regional lymph nodes., OS – time from enrolment to the date of death of any cause Feasibility rate - severe toxicity/withdrawal rate before the last postoperative administration of pembrolizumab/trastuzumab/FLOT has been completed., (Serious) adverse events - recorded and graded according to NCI-CTCAE V5.0. Occurrence of (serious) adverse events at any time during the study. Description by nature (System Organ Class and Preferred Term), severity and causal relationship to drug administration. | — |
Countries
Germany
Outcome results
None listed