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
Single group
Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1
DrugIt is the first study which evaluate efficacy and safety of anti PD-1 immune checkpoint inhibitor alone in the first-line treatment of elderly esophageal squamous-cell carcinoma patients who no fit to received chemotherapy with platine
To assess the 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 ESCC
to assess the rate of evaluable patients (i.e., those not lost to follow-up at 6 months and who have received at least one dose of the study treatment) who are alive at 6 months after inclusion to patient rate measurement
Safety according to NCI-CTCAE version 5.0
all grade and severe (grade 3-5) toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, will be recorded until 90 days after the last administration of treatment
- Overall survival (OS) at 6 months depending on PD-L1 expression
Overall survival (OS) will be estimated by the time between the date of the first dose treatment with tislelizumab and the date of death (whatever the cause) or date of last news for alive patients
- Overall response rate (ORR) according to RECIST 1.1 criteria
The Overall Response Rate (ORR): is defined as the proportion of patients who achieved complete response (CR) or partial response (PR) as the best response during the treatment. evaluated by the investigator 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
Progression free survival (PFS) is defined by the time between the date of the first dose treatment with tislelizumab and the date of first progression (clinical and/or radiological; RECIST 1.1 criteria) determined by the investigator, or date of death (whatever the cause), whichever occurs first. Patients alive without progression will be censored at the date of last news.
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University Hospital, Clermont-Ferrand
Lead sponsor
BeiGene USA, Inc.
Collaborator
Federation Francophone de Cancerologie Digestive
Collaborator
