TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY
NCT04481256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2024-07-26
Summary
The primary objective of this study is to assess the feasibility of treatment with bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.
Conditions
- Carcinoma, Squamous Cell
- Oesophageal Cancer
Interventions
- RADIATION
-
External beam radiotherapy
External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy
- DRUG
-
Bintrafusp alfa
Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
- DRUG
-
Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
- DRUG
-
Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
Sponsors & Collaborators
-
UMC Utrecht
collaborator OTHER -
Catharina Ziekenhuis Eindhoven
collaborator OTHER -
Institute Verbeeten
collaborator OTHER -
Elisabeth-TweeSteden Ziekenhuis
collaborator OTHER -
Leiden University Medical Center
collaborator OTHER -
Radiotherapeutic Institute Friesland
collaborator OTHER -
Frisius Medisch Centrum
collaborator OTHER -
Radiotherapy Group Deventer
collaborator OTHER -
Deventer Ziekenhuis
collaborator OTHER -
Rijnstate Hospital
collaborator OTHER - collaborator OTHER
-
The Netherlands Cancer Institute
collaborator OTHER -
Isala
collaborator OTHER -
University Medical Center Groningen
collaborator OTHER -
Ziekenhuisgroep Twente
collaborator OTHER -
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Principal Investigators
-
Hanneke WM van Laarhoven, MD,PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-11
- Primary Completion
- 2025-09-01
- Completion
- 2030-09-01
Countries
- Netherlands
Study Locations
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