Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * Pathologically documented adenocarcinoma of the stomach (clinical stage before surgery of AJCC I-III), gastroesophageal junction, or lower oesophagus (to include Type I Siewert only), with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results. * ctDNA positive after surgery as per Signatera assay * Capable of giving signed informed consent prior to any mandatory study specific procedures, sampling, or analyses and which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Male and female participants must be at least 18 years of age at the time of signing the ICF. * Treated with neoadjuvant chemotherapy before surgery for at least six weeks. * Surgical resection with clear margins (R0). * Recovered from surgery in the opinion of the investigator. * No previous treatment with trastuzumab or other HER2 directed therapy. * No evidence of metastatic disease on post-surgical CT. * Has an Easter