Actively Recruiting
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2024-06-13
46
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the activity, efficacy, and safety of trastuzumab-deruxtecan (T-DXd) combined with capecitabine or 5-fluorouracil as a post-operative treatment in patients with localized or locally advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma cancers that overexpress or amplify HER2. This phase II multicenter, randomized, open-label study targets patients who have positive circulating tumor DNA (ctDNA) after pre-operative chemotherapy with FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) followed by radical surgery. The study aims to improve understanding of treatment effects in this specific patient group identified by minimal residual disease detected by liquid biopsy. The trial includes an observational phase where patients receive standard pre-operative FLOT chemotherapy and surgery while undergoing multiple liquid biopsies to detect ctDNA. Eligible patients with positive post-operative ctDNA are randomized to receive either the experimental treatment of T-DXd at 6.4 mg/kg intravenously every 3 weeks combined with either capecitabine orally or 5-fluorouracil infusion for six cycles, or the control arm receiving post-operative FLOT chemotherapy for four cycles. The study includes pre-screening, screening, treatment, and follow-up phases with scheduled CT scans and echocardiography. Participants will have several assessments including blood samples for ctDNA at baseline, end of pre-operative treatment, post-surgery, and at multiple time points after randomization. Imaging scans occur every three months for one year to monitor for disease relapse. The primary outcome is ctDNA clearance measured at one year post-randomization. Secondary outcomes include disease-free survival, overall survival, metastases-free survival, quality of life during treatment, and safety over six months. The total participation may extend up to three years with continued follow-up and monitoring.
CONDITIONS
Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 12 weeks after surgery
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit including CT scan and echocardiography
Duration - Approximately 18 weeks for experimental treatment or 8 weeks for control treatment
Participants receive either 6 cycles of T-DXd plus capecitabine or 5-fluorouracil every 3 weeks, or 4 cycles of post-operative FLOT chemotherapy.
Every 2 to 3 weeks during treatment cycles
Duration - Up to 1 year after treatment
Participants undergo CT scans every 3 months for 1 year to monitor for disease relapse and have exploratory liquid biopsies collected at 3, 6, and 12 months post-randomization. Additional liquid biopsies occur during follow-up visits as per standard clinical practice.
CT scans every 3 months and liquid biopsies at 3, 6, and 12 months post-randomization
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy, 20133
Actively Recruiting
F
Filippo Pietrantonio, MD
F
Federica Palermo
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Vincenzo Nasca, Francesca Bergamo, Luisa Foltran...
https://pubmed.ncbi.nlm.nih.gov/40200187