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
This is a multicenter open-label single arm phase II study to evaluate Tislelizumab in monotherapy in frontline metastatic or locally advanced ESCC. Patient aged ≥70 years will be selected for inclusion after a diagnosis of metastatic or locally advanced ESCC, and if they are not eligible for a platinum-based chemotherapy regimen. Tislelizumab (200 mg flat dose every 3 weeks) will be received by intravenous perfusion until progression or unacceptable toxicity, for a maximum of 2 years. The patients will be included regardless of PD-L1 status; A comparison for all study population will be carried out centrally as part of the ancillary enquiries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
It 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
Centre Hospitalier Annecy Genevois
Annecy, Epagny Metz-Tessy, France
NOT_YET_RECRUITINGInstitut régional du cancer Provence d'Avignon
Avignon, France
NOT_YET_RECRUITINGCentre Hospitalier de la Côte Basque
Bayonne, France
NOT_YET_RECRUITINGCHU Besançon
Besançon, France
RECRUITINGCH Béthune et Beuvry
Beuvry, France
RECRUITINGICHF Centre Pierre Curie
Beuvry, France
RECRUITINGCHU Clermont-Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGCHU Dijon
Dijon, France
NOT_YET_RECRUITINGGroupe Hospitalier Mutualiste
Grenoble, France
NOT_YET_RECRUITINGCHRU Lille
Lille, France
RECRUITING...and 10 more locations
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
Time frame: 6 month after inclusion
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
Time frame: time between the date of the first dose treatment with tislelizumab and the date within the 90 days after the last dose 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
Time frame: 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.
Time frame: the time between the date of the first dose treatment with tislelizumab and the date of last dose of treatment
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.
Time frame: at 3 month and 6 month after inclusion
Patients' health according the questionnary quality of life C30 of EORTC
Quality of life will be assessed with the questionnary quality of life C30 of EORTC (version 3.0) at each evaluation. Each questionnaire will be scored according to the relevant scoring manual. If half or more of the elements, which calculate a scale, are missing then the scale will be set to missing as per the scoring manuals. A scale cannot be estimated for the single item scales if the question they relate to has not been answered
Time frame: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment
Patients' health according the questionnary quality of life OES-18 of EORTC
Quality of life will be assessed with the questionnary quality of life OES-18 of EORTC at each evaluation. Each questionnaire will be scored according to the relevant scoring manual. If half or more of the elements, which calculate a scale, are missing then the scale will be set to missing as per the scoring manuals. A scale cannot be estimated for the single item scales if the question they relate to has not been answered
Time frame: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment
Patients' health according the questionnary quality of life ELD14 of EORTC
Quality of life will be assessed with the questionnary quality of life ELD14 of EORTC at each evaluation. Each questionnaire will be scored according to the relevant scoring manual. If half or more of the elements, which calculate a scale, are missing then the scale will be set to missing as per the scoring manuals. A scale cannot be estimated for the single item scales if the question they relate to has not been answered
Time frame: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment
Geriatric assessment according the questionnary G-CODE
Geriatric assessment will be performed at baseline and during treatment using the complete G-CODE which assesses the patient's autonomy in their daily life
Time frame: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment
Prognostic value of immune biomarkers
All patients, participating in the clinical study, will have blood drawn for the biological assessments at baseline and at the first radiological tumoral evaluation.
Time frame: the time between the date of the first dose treatment with tislelizumab and the first radiological tumoral evaluation at 9 weeks after C1J1
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