RecruitingNot ApplicableNCT04481256

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


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

49 participants

Start Date

Nov 11, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immunotherapy drugs — one that blocks a protein called TGF-β and another that blocks PD-L1 — given alongside standard chemotherapy and radiation for esophageal squamous cell cancer. The goal is to improve tumor control and survival. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the esophagus or the junction of the esophagus and stomach, confirmed by biopsy - Your cancer cannot be removed by surgery, or you have refused surgery - You have locally advanced disease without spread to distant organs (except possibly the neck lymph nodes) - You have had a local recurrence after prior treatment, provided it is outside the previously treated area **You may NOT be eligible if...** - Your cancer has spread widely to distant organs - You have already received prior radiation in the area that would be re-treated - You are pregnant or have significant health conditions that prevent chemotherapy or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONExternal 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

DRUGBintrafusp alfa

Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.

DRUGPaclitaxel

Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.

DRUGCarboplatin

Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.


Locations(1)

Academic Medical Center, Medical Oncology

Amsterdam, Netherlands

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NCT04481256


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