At a glance
ClinicalIndex Comparison Record- ✓Resected gastric or gastroesophageal junction cancer after pre-operative FLOT chemotherapy
- ✓Absence of distant metastases by post-operative imaging
- ✓HER2 overexpression/amplification on post-treatment surgical tissue (IHC 3+ or 2+/ISH amplified)
- ✓ctDNA positivity on post-operative liquid biopsy 2-6 weeks after surgery
- ✕Distant metastases at any site
- ✕History of myocardial infarction within 6 months
- ✕Symptomatic congestive heart failure NYHA Class II-IV
- ✕QTcF prolongation >470 msec (females) or >450 msec (males)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Experimental and Control for Gastric Cancer and HER2-positive Gastric Cancer. Currently recruiting, targeting 46 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
6 cycles of: T-DXd at the dose of 6.4 mg/kg intravenous every 3 weeks plus capecitabine 1000 mg/sqm BID orally on days 1-14 every 3 weeks or 5-fluorouracil 600 mg/m2/day continuous intravenous infusion on days 1-5 every 3 weeks as per Investigator's choice
4 cycles of: 5-fluorouracil 2600 mg/m2 continuous intravenous infusion day 1 for 24 hours every 2 weeks, leucovorin 200 mg/m2 intravenous infusion on day 1 every 2 weeks, oxaliplatin 85 mg/m2 intravenous infusion on day 1 every 2 weeks, and docetaxel 50 mg/m2 intravenous infusion on day 1 every 2 weeks.