NCT04481256

TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. 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.

Conditions

• Carcinoma, Squamous Cell
• Oesophageal Cancer

Interventions

Type	Name	Description
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	Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
DRUG	Carboplatin	Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.

Timeline

• Start date: 2020-11-11
• Primary completion: 2025-09-01
• Completion: 2030-09-01
• First posted: 2020-07-22
• Last updated: 2024-07-26

Locations

1 site across 1 country: Netherlands