OncoMatch/Clinical Trials/NCT06253650
Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease
Is NCT06253650 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Experimental for gastric cancer.
Treatment: Experimental — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or 2+/ISH amplified)
Presence of locally determined HER2 overexpression/amplification on the post-treatment surgical tissue specimen defined as IHC 3+ or 2+/ISH amplified
Required: HER2 (ERBB2) amplification (IHC 3+ or 2+/ISH amplified)
Presence of locally determined HER2 overexpression/amplification on the post-treatment surgical tissue specimen defined as IHC 3+ or 2+/ISH amplified
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (FLOT) — pre-operative
after the completion of pre-operative chemotherapy with FLOT
Cannot have received: HER2-targeted therapy
Prior treatment with an anti-HER2 agent
Lab requirements
Blood counts
Neutrophil count ≥ 1.5 x 10^3/μL; Platelet count ≥ 100 x 10^6/μL; Haemoglobin ≥ 9 g/dL; International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN
Kidney function
Creatinine clearance > 60 mL/min
Liver function
Total bilirubin < 1.5 x ULN; AST (SGOT) and/or ALT (SGPT) < 3 x ULN; serum albumin ≥ 2.5 g/dL
Cardiac function
LVEF ≥ 50% within 28 days before randomization/enrolment; QTcF ≤ 470 msec (females) or ≤ 450 msec (males)
Adequate bone marrow and organ function within 14 days before randomization/enrolment as described below: ... LVEF ≥ 50% within 28 days before randomization/enrolment. Corrected QT interval (QTcF) prolongation to > 470 msec (females) or >450 msec (males) based on average of the screening triplicate12-lead ECG [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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