PRODIGE 102 - FFCD 2201 - SAFE-ESO Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma
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
• 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 use a condom during treatment and for 6 months after the last dose when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential during treatment and for 6 months after the last dose.
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up.
• Signed written informed consent obtained prior to any study specific procedures
• Patient affiliated to a social security scheme