Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 * At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria * Patients ≥ 70 years * Subjects with WHO performance status ≤ 2 * Estimated life expectancy \>3 months * Adjuvant therapy finished \>6 months * Adequate marrow and organ functions defined as: * Absolute neutrophil count (ANC) ≥ 1 × 109/L, * Platelet count ≥ 75 × 109/L, * Hemoglobin ≥ 90 g/L, * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN, or AST and ALT ≤5 ×ULN for patients with liver metastases * ALP ≤ 5 x ULN unless liver metastases are present, in which case it must be ≤ 10x ULN * Measured creatinine clearance (CL) \> 40 mL/min (MDRD method) * Male patients must u