OncoMatch/Clinical Trials/NCT05188313
TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer
Is NCT05188313 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Trastuzumab and Pertuzumab for esophageal cancer.
Treatment: Trastuzumab · Pertuzumab · Paclitaxel · Carboplatin — Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted treatment options are currently available, hampering personalized treatment for this patient population. TRAP-2 aims to address these needs by investigating whether addition of trastuzumab and pertuzumab to standard of care improves survival of patients with resectable HER2 positive esophageal adenocarcinoma (HER2+ EAC). Patients with HER2+ EAC will be randomised to neoadjuvant chemoradiation according to the CROSS regimen or CROSS + TRAstuzumab and Pertuzumab. Primary outcome is overall survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+ with ish+)
Disease stage
Required: Stage T1N+M0, T2-T4A N0 OR N+ M0
Excluded: Stage T1N0
T1N+M0; or T2-T4a N0 or N+ M0). T1N0 tumors or in situ carcinoma [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Previous chemotherapy...for esophageal cancer
Cannot have received: radiotherapy
Previous...radiotherapy...for esophageal cancer
Cannot have received: anti-HER2 antibody
Previous...treatment with an anti-HER2 antibody...for esophageal cancer
Cannot have received: small molecule HER2 inhibitor
Previous...treatment with...small molecule HER2 inhibitors for esophageal cancer
Cannot have received: chemotherapy
Previous chemotherapy...for any other cancer within 6 months of diagnosis of esophageal cancer
Cannot have received: radiotherapy
Previous...radiotherapy...for any other cancer within 6 months of diagnosis of esophageal cancer
Cannot have received: anti-HER2 antibody
Previous...treatment with an anti-HER2 antibody...for any other cancer within 6 months of diagnosis of esophageal cancer
Cannot have received: small molecule HER2 inhibitor
Previous...treatment with...small molecule HER2 inhibitors for any other cancer within 6 months of diagnosis of esophageal cancer
Lab requirements
Blood counts
Neutrophils ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 5.6 mmol
Kidney function
Creatinine clearance (Cockroft) > 60 ml/min
Liver function
Total bilirubin ≤ 1.5 x upper normal limit
Cardiac function
LVEF ≥55% determined by transthoracic echocardiography or MUGA
Adequate hematological, renal and hepatic functions defined as: Neutrophils ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 5.6 mmol; Total bilirubin ≤ 1.5 x upper normal limit; Creatinine clearance (Cockroft) > 60 ml/min. Adequate left ventricular ejection fraction defined as an LVEF of ≥55% determined by transthoracic echocardiography or MUGA.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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