The goal of this clinical trial is to assess the percentage of patients alive at 6 months in elderly patients, not eligible to an platinum-based chemotherapy, but who can received the Tislelizumab treatment alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC).
Tislelizumab is a monoclonal antibody administred by intravenous infusion
This study aims to anwer too at the questions:
* the Safety of the drug * Overall survival (OS) at 6 months according the diagnostic of PD-L1 expression (PD-L1 is a protein present on the surface of immune cells) * Overall response rate (ORR) according to imagery criteria * Progression-free survival (PFS) at 3 and 6 months according to imagery criteria and depending on PDL1 expression * Patients' health-related quality of life * OS and PFS according to geriatric parameters * Prognostic value of immune biomarkers
Histologically proven esophageal squamous cell carcinoma (ESCC)
Metastatic or locally advanced cancer
Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician
Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of treatment
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
University Hospital, Clermont-Ferrand
Lead sponsor
BeiGene USA, Inc.
Collaborator
Federation Francophone de Cancerologie Digestive
Collaborator