DECIPHER: A single arm phase II trial of trastuzumab deruxtecan in patients with gastrooesophageal adenocarcinoma cancer who are ctDNA and HER2 positive. (DECIPHER)

Research summary

This is a single stage,single arm phase II,open,label,multi centre trial of patients with HER2 positive GOA who are ctDNA positive following neoadjuvant chemotherapy and surgery. HER2 positive will be defined as IHC3+ or IHC2+/ISH+ positive on diagnostic biopsy or resection specimen. ctDNA result will be determined using the Natera Signatera assay. All patients will be treated with trastuzumab deruxtecan at a dose of 6.4 mg/kg intravenously every 21 days for 6 months. If required patients may dose reduce to 5.4 mg/kg or 4.4 mg/kg. No dose re-escalation is permitted. Patients will receive 12 weekly CT scans and ctDNA blood samples throughout the trial,which will be used to ascertain disease status. Patients will also receive a physical exam,blood tests and a pregnancy test for women of childbearing potential at the start of each cycle. The aim of the trial is to treat the minimal residual disease reducing the chance of relapse. All trial patients will be followed for up to 2 years to record their response to treatment.

Principal Investigator

Dr Paul Miller

Contact us

Email: latephaseoncology@ouh.nhs.uk

IRAS number

1006810