RecruitingPhase 2NCT05965479

Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer

A Single Arm Phase II Trial of Trastuzumab Deruxtecan in Patients With Gastrooesophageal Adenocarcinoma Cancer Who Are ctDNA and HER2 Positive

Sponsor

University of Southampton

Enrollment

25 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Gastrooesophageal Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether continuing targeted therapy with trastuzumab (a HER2-targeting drug) after surgery can improve outcomes for patients with HER2-positive stomach or esophageal junction cancer who still have detectable circulating tumor DNA (ctDNA) in their blood after their operation — a sign that microscopic cancer may remain. **You may be eligible if...** - You have confirmed HER2-positive stomach, gastroesophageal junction, or lower esophageal adenocarcinoma (cancer of the lining) - Your blood test (Signatera assay) is positive for ctDNA after surgery, suggesting residual microscopic cancer - Your cancer was stage I–III before surgery - You are willing and able to follow the study protocol **You may NOT be eligible if...** - Your ctDNA test is negative after surgery - Your cancer does not overexpress HER2 - You have had previous treatment for this type of cancer before this study - You have serious heart, kidney, or liver problems that prevent trastuzumab use 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

DRUGTrastuzumab deruxtecan

Trastuzumab deruxtecan is an antibody-drug conjugate that contains trastuzumab covalently linked to deruxtecan, a topoisomerase I inhibitor. It is given by intravenous infusion.

Locations(14)

Royal Surrey NHS Foundation Trust, Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

University Hospitals Coventry and Warwickshire, University Hospital Coventry

Coventry, Warwickshire, United Kingdom

Belfast Health and Social Care Trust, Belfast City Hospital

Belfast, United Kingdom

Cambridge University Hospital NHS Foundation Trust, Addenbrookes Hospital

Cambridge, United Kingdom

University Hospitals of Derby and Burton NHS Foundation Trust, Royal Derby Hospital

Derby, United Kingdom

NHS Tayside, Ninewells Hospital

Dundee, United Kingdom

Hull University Teaching Hospitals NHS Trust, Castel Hill Hospital

Hull, United Kingdom

Leeds Teaching Hospitals NHS Trust, St James's University Hospital

Leeds, United Kingdom

University College London Hospitals NHS Foundation Trust, University College Hospital London

London, United Kingdom

Guys & St Thomas NHS Foundation Trust, Guy's Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Oxford University Hospitals NHS Trust, Churchill Hospital

Oxford, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust, Royal Preston Hospital

Preston, United Kingdom

Velindre University NHS Trust, Velindre Cancer Centre

Whitchurch, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05965479