Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease

Summary

TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine/5-fluorouracil as a post-operative treatment in localized/locally advanced gastric or gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma patients with HER2 overexpression/amplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.

Timeline

Start

2024-03-01

Primary completion

2027-03-01

Completion

2028-03-01

Publications

• Nasca V, Bergamo F, Foltran L, Antonuzzo L, Bencardino K, Dell'Aquila E, Corallo S, Spallanzani A, Brunetti O, Spada D, Tamberi S, Cella CA, Avallone A, Fornaro L, Di Donato S, Strippoli A, Puccini A, Tamburini E, Palermo F, Morano F, Pietrantonio F, Raimondi A. Adjuvant TRastuzumab deruxtecan plus fluoropyrimidine versus standard chemotherapy in HER2-positive gastric or gastroesophageal cancer patients with persistence of minimal residual disease in liquid biopsy after pre-operative chemotherapy and radical surgery: the multicentre, phase II randomized TRINITY trial. BMC Cancer. 2025 Apr 8;25(1):633. doi: 10.1186/s12885-025-14063-6.

Drugs

Indications