Actively Recruiting
Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2024-06-13
46
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be 18 years old or older
- Have ECOG Performance Status 0 or 1
- Have a life expectancy of at least 12 weeks
- Have resected gastric, gastroesophageal junction (Siewert I-II-III), or esophageal adenocarcinoma after pre-operative FLOT chemotherapy
- Have no distant metastases based on post-operative imaging
- Have HER2 overexpression or amplification confirmed on post-treatment surgical tissue
- Have positive post-operative ctDNA detected 2-6 weeks after surgery
- Have left ventricular ejection fraction (LVEF) of 50% or higher within 28 days before enrollment
- Have adequate bone marrow and organ function within 14 days before enrollment, including neutrophil count ≥ 1.5 x 10³/µL, platelet count ≥ 100 x 10⁶/µL, hemoglobin ≥ 9 g/dL, total bilirubin less than 1.5 times upper normal limit, AST/ALT less than 3 times upper normal limit, serum albumin ≥ 2.5 g/dL, creatinine clearance > 60 mL/min, and coagulation tests ≤ 1.5 times upper normal limit
- For females of childbearing potential, have a negative pregnancy test and use highly effective contraception during the study and for 7 months after the last dose
- For non-sterilized males sexually active with females of childbearing potential, use condoms with spermicide during the study and for 4 months after the last dose
- Agree not to donate or retrieve ova during the study and for at least 7 months after the last dose
- Be willing and able to comply with study treatments and follow-up at the participating center
You will not qualify if you...
- Involvement in planning or conducting the study
- Participation in another clinical trial with an investigational product within the last 12 months
- Presence of distant metastases
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, arrhythmias, renal or neurological diseases, severe gastrointestinal conditions, substance abuse, or psychiatric/social conditions limiting study participation
- History of myocardial infarction within 6 months, symptomatic congestive heart failure (NYHA class II-IV), or elevated troponin without symptoms without cardiology clearance
- Prolonged corrected QT interval (>470 msec for females, >450 msec for males)
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected by imaging
- Significant lung diseases or autoimmune conditions with pulmonary involvement
- Prior complete pneumonectomy
- Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, uncontrolled HIV, or active hepatitis B or C infection
- Receipt of live attenuated vaccines within 30 days before first dose
- Unresolved toxicities from prior cancer treatment above grade 1 except stable chronic grade 2
- Known allergies or severe hypersensitivity to study drugs or monoclonal antibodies
- Pregnant or breastfeeding, or planning pregnancy
- Multiple primary cancers within 3 years except certain treated skin or in-situ diseases
- Presence of pleural, pericardial, or ascitic effusions requiring drainage
- Left ventricular ejection fraction below 50%
- Prior treatment with anti-HER2 agents
- Lack of HER2 overexpression/amplification on surgical specimen
- Negative post-operative ctDNA
- Known deficiency of dihydropyrimidine dehydrogenase enzyme before starting pre-operative FLOT chemotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy, 20133
Actively Recruiting
Research Team
F
Filippo Pietrantonio, MD
CONTACT
F
Federica Palermo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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