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Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer

NCT05965479 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Gastrooesophageal Cancer

Interventions

DRUG

Trastuzumab 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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Natera, Inc.

    collaborator INDUSTRY

  • University of Southampton

    lead OTHER

Principal Investigators

  • Elizabeth Smyth · University of Oxford

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2026-03-31
Completion
2028-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965479 on ClinicalTrials.gov