Squamous cell carcinoma of the esophagus
Conditions
Brief summary
Percentage of patients alive at 6 months in elderly patients, not eligible to platinum-based chemotherapy, treated by anti-PD1 Tislelizumab alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC).
Detailed description
• Safety according to NCI-CTCAE version 5.0, • Overall survival (OS) at 6 months depending on PD-L1 expression, • Overall response rate (ORR) according to RECIST 1.1 criteria, • Progression-free survival (PFS) at 3 and 6 months according to RECIST 1.1 criteria and depending on PDL1 expression, • Patients’ health-related quality of life (EORTC QLQC30, OES-18 and QLQ-ELD14 scales), • OS and PFS according to geriatric parameters (complete G-CODE, and ADL and IADL sub-scales), • Prognostic value of immune biomarkers
Interventions
Sponsors
University Hospital Of Clermont-Ferrand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients alive at 6 months in elderly patients, not eligible to platinum-based chemotherapy, treated by anti-PD1 Tislelizumab alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety according to NCI-CTCAE version 5.0, • Overall survival (OS) at 6 months depending on PD-L1 expression, • Overall response rate (ORR) according to RECIST 1.1 criteria, • Progression-free survival (PFS) at 3 and 6 months according to RECIST 1.1 criteria and depending on PDL1 expression, • Patients’ health-related quality of life (EORTC QLQC30, OES-18 and QLQ-ELD14 scales), • OS and PFS according to geriatric parameters (complete G-CODE, and ADL and IADL sub-scales), • Prognostic value of immune biomarkers | — |
Countries
France
Outcome results
None listed