drugset / Trial / NCT04150640
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-07-13
- Primary completion
- 2027-12
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan Sucrosofate | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |
| Subject | Oxaliplatin | Small molecule | 60 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | — |
| Subject | Trastuzumab | Monoclonal antibody | 4 mg/kg | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |