RecruitingPhase 2NCT06253650

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

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

Sponsor

Gruppo Oncologico del Nord-Ovest

Enrollment

46 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer HER2-positive Gastric Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called TRINITY) tests whether adding trastuzumab deruxtecan (T-DXd, a targeted antibody-drug therapy) after surgery and pre-operative chemotherapy improves outcomes in patients with HER2-positive stomach or lower esophageal cancer. HER2-positive means the tumor has extra copies of the HER2 protein, which drives cancer growth and can be targeted with specific drugs. **You may be eligible if...** - You are 18 or older and have had surgery for stomach or gastroesophageal junction cancer - Your tumor is confirmed HER2-positive - You completed pre-operative chemo and surgery, and your tumor was not completely destroyed by the pre-op treatment - Your general health is good (ECOG status 0–1) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your cancer has already spread to distant organs - You have pre-existing serious heart, lung, or liver conditions - You have had prior treatment with HER2-targeted therapy (in some cases) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExperimental

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

DRUGControl

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.