Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
NCT05170256 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-08-12
Summary
The study aims to determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with HER2 positive Esophageal squamous cell carcinoma (ESCC) determined by 6 months progression free survival (PFS) (RECIST 1.1).
Conditions
- Esophageal Squamous Cell Carcinoma
- HER-2 Protein Overexpression
- HER-2 Gene Amplification
Interventions
- DRUG
-
Addition of trastuzumab to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab)
Sponsors & Collaborators
-
Odense University Hospital
collaborator OTHER -
Aalborg University Hospital
collaborator OTHER -
Aarhus University Hospital
collaborator OTHER -
Morten Mau-Sørensen
lead OTHER
Principal Investigators
-
Lene Baeksgaard, MD PhD · Rigshospitalet, Denmark
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-04
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
Countries
- Denmark
Study Locations
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