PDL-1 Targeting in Resectable Oesophageal Cancer

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID: NCT03087864
Phase: PHASE2
Status: Completed

Conditions

Esophageal Cancer Stage III
Esophageal Cancer, Stage II

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Atezolizumab — DRUG
Atezolizumab 1200 mg i.v. day 1-22-43-64-85
Carboplatin — DRUG
Chemotherapy
Paclitaxel — DRUG
Chemotherapy
Radiotherapy 23 x 1.8 Gy — RADIATION
Radiotherapy

Study Details

Objectives The primary objective of this study is to assess the feasibility of preoperative treatment with atezolizumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of completion of treatment with atezolizumab.

Key Dates

Start date: Jun 28, 2017
Status verified: May 2020
Primary completion: Jul 1, 2019
Completion: Jul 1, 2019

Study Design

Enrollment: 40 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Atezolizumab and Chemoradiation
Atezolizumab 1200 mg i.v. day 1-22-43-64-85 Carboplatin AUC = 2 i.v day 1-8-15-22-29 Paclitaxel 50 mg/m2 i.v day 1-8-15-22-29 Radiotherapy 23 x 1.8 Gy

Primary Outcome Measure

feasibility defined as percentage completion of treatment with atezolizumab. [ Time Frame: up to 3 months ]