OncoMatch/Clinical Trials/NCT05965479
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
Is NCT05965479 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trastuzumab deruxtecan for gastrooesophageal cancer.
Treatment: Trastuzumab deruxtecan — Multicentre, single arm, open label UK phase II trial to assess the efficacy of trastuzumab deruxtecan in reducing micrometastatic disease burden in HER2 positive GOA patients who are ctDNA positive after chemotherapy and surgery. 25 patients will be recruited from approximately 15 NHS secondary care sites.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+/ish+)
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — neoadjuvant
Treated with neoadjuvant chemotherapy before surgery for at least six weeks.
Cannot have received: HER2-targeted therapy (trastuzumab)
No previous treatment with trastuzumab or other HER2 directed therapy.
Lab requirements
Blood counts
Platelet count ≥ 100x10^9/L (no platelet transfusion within 1 week, no thrombopoietin receptor agonists within 2 weeks); Haemoglobin ≥ 80 g/L (no transfusions or growth factor support within 1 week); Absolute neutrophil count ≥ 1.5 x 10^9/L (no G-CSF within 1 week)
Kidney function
Creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault equation
Liver function
ALT/AST ≤ 3 x ULN; Total bilirubin ≤ 1.5 x ULN or < 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia); Serum albumin ≥ 3.0 g/dl
Cardiac function
LVEF ≥ 50% by ECHO or MUGA within 28 days before treatment; Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG [excluded]
Has LVEF ≥ 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before treatment. Platelet count ≥ 100x10^9/L... Haemoglobin ≥ 80 g/L... Absolute neutrophil count ≥ 1.5 x 10^9/L... ALT/AST ≤ 3 x ULN... Total bilirubin ≤ 1.5 x ULN or < 3 x ULN in the presence of documented Gilbert's Syndrome... Serum albumin ≥ 3.0 g/dl... Creatinine clearance ≥ 50 mL/min... Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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