Clinical Trial

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

Study acronym: TRINITY
Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-02-02.
Status change: Not Yet Recruiting → Recruiting 2024-06-12
Trial Details
NCT Number NCT06253650
Lead Sponsor Gruppo Oncologico del Nord-Ovest
Conditions Gastric Cancer, HER2-positive Gastric Cancer
Enrollment 46 participants
Start Date 2024-03-01
Primary Completion 2027-03-01 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-06-13