Actively Recruiting
Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma
Led by University Hospital, Clermont-Ferrand · Updated on 2026-04-28
95
Participants Needed
30
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Clermont-Ferrand
Lead Sponsor
B
BeiGene USA, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven esophageal squamous cell carcinoma (ESCC)
- Metastatic or locally advanced cancer
- No prior treatment with immunotherapy, chemotherapy, or radiotherapy in the first-line setting
- Not eligible for platinum-based chemotherapy as assessed by oncologist and geriatrician
- At least one evaluable or measurable tumor lesion according to RECIST v1.1
- Age 70 years or older
- WHO performance status of 2 or less
- Estimated life expectancy greater than 3 months
- Completed adjuvant therapy more than 6 months ago
- Adequate marrow and organ functions (ANC ≥ 1 x 10^9/L, platelet count ≥ 75 x 10^9/L, hemoglobin ≥ 90 g/L, AST and ALT ≤ 3 x ULN or ≤ 5 x ULN if liver metastases present, ALP ≤ 5 x ULN or ≤ 10 x ULN if liver metastases, creatinine clearance > 40 mL/min)
- Male patients agree to use condoms during treatment and for 6 months after last dose if sexually active with pregnant or childbearing potential women; female partners of male patients agree to use effective contraception during treatment and for 6 months after last dose
- Willing and able to comply with study protocol including treatment, visits, and examinations
- Signed informed consent obtained
- Affiliated with a social security scheme
You will not qualify if you...
- History of another primary cancer except if treated with curative intent and no active disease for at least 2 years
- Adequately treated non-melanoma skin cancer or carcinoma in situ without disease
- Locally advanced esophageal cancer that is resectable or potentially curable with radiation
- Participation in another clinical study with investigational product within past 2 months
- Concurrent enrollment in another interventional clinical study unless observational or follow-up only
- History of allogenic organ, bone marrow, or cord blood transplantation
- Active autoimmune or inflammatory disorders except certain stable conditions (e.g., vitiligo, alopecia, hypothyroidism on hormone replacement)
- Previous immune checkpoint inhibitor therapy within 2 years before inclusion
- Uncontrolled illnesses such as uncontrollable pleural or pericardial effusion, ascites requiring frequent intervention
- Evidence of esophageal fistula
- Serious uncontrolled medical disorders or psychiatric conditions that impair consent or study compliance
- History of severe hypersensitivity to monoclonal antibodies
- Received chemotherapy, immunotherapy, or investigational therapies within 14 days or 5 half-lives before study drug
- Myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic central nervous system metastases
- Active primary immunodeficiency
- Uncontrolled HIV infection with CD4 count below 400/mm3
- Active infection including tuberculosis, untreated hepatitis B or C
- Use of immunosuppressive medication within 14 days before first dose except certain exceptions
- Receipt of live attenuated vaccine within 30 days before first dose
- Inability to comply with follow-up or study protocol
- Legal or psychiatric conditions affecting consent or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Centre Hospitalier Annecy Genevois
Annecy, Epagny Metz-Tessy, France, 74370
Not Yet Recruiting
2
CHU Amiens
Amiens, France
Not Yet Recruiting
3
Institut régional du cancer Provence d'Avignon
Avignon, France
Not Yet Recruiting
4
Centre Hospitalier de la Côte Basque
Bayonne, France, 64100
Not Yet Recruiting
5
CHU Besançon
Besançon, France
Actively Recruiting
6
CH Béthune et Beuvry
Beuvry, France
Actively Recruiting
7
ICHF Centre Pierre Curie
Beuvry, France
Actively Recruiting
8
CHRU Brest
Brest, France
Actively Recruiting
9
Centre François Baclesse
Caen, France
Actively Recruiting
10
CHU Clermont-Ferrand
Clermont-Ferrand, France
Not Yet Recruiting
11
CHU Dijon
Dijon, France
Not Yet Recruiting
12
Groupe Hospitalier Mutualiste
Grenoble, France
Not Yet Recruiting
13
CHRU Lille
Lille, France
Actively Recruiting
14
CHU Limoges
Limoges, France
Not Yet Recruiting
15
Centre Léon BERARD de Lyon
Lyon, France
Not Yet Recruiting
16
CHU Nancy
Nancy, France
Actively Recruiting
17
Hôpital Européen Georges-Pompidou
Paris, France
Actively Recruiting
18
Hôpital Saint-Louis Lariboisière
Paris, France
Actively Recruiting
19
Le Groupe Hospitalier Diaconesses Croix Saint-Simon de Paris
Paris, France
Actively Recruiting
20
Centre hospitalier de Perpignan
Perpignan, France
Not Yet Recruiting
21
CHU Poitiers
Poitiers, France
Actively Recruiting
22
Centre Régional du Lutte Contre Le Cancer - Institut Godinot
Reims, France, 51726
Not Yet Recruiting
23
CHU de Reims
Reims, France
Not Yet Recruiting
24
CHU Rennes
Rennes, France
Actively Recruiting
25
CHU Rouen
Rouen, France
Actively Recruiting
26
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Actively Recruiting
27
Groupe Hospitalier Rance Emeraude
St-Malo, France
Actively Recruiting
28
ICAN Strasbourg
Strasbourg, France
Not Yet Recruiting
29
CHRU Tours
Tours, France
Not Yet Recruiting
30
Médipôle Hôpital Mutualiste
Villeurbanne, France
Actively Recruiting
Research Team
L
Lise Laclautre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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