Clinical trial • Phase IV • Oncology
Tislelizumab for Esophageal squamous cell carcinoma | Advanced esophageal squamous cell carcinoma
Phase IV trial of Tislelizumab for Esophageal squamous cell carcinoma | Advanced esophageal squamous cell carcinoma. 95 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Esophageal squamous cell carcinoma | Advanced esophageal squamous cell carcinoma
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 23-01-2025
- First CTIS Authorization Date
- 17-04-2025
Trial design
Phase IV trial across 30 sites in France.
- Target Sample Size
- 95
Eligibility
Recruits 95 Vulnerable population not selected. Exclusion criterion: 'Persons deprived of liberty or under guardianship or incapable of giving consent'. Trial enrols capable adult participants only (no children); incapable persons are excluded and informed consent from capable adult participants is required..
- Vulnerable Population
- Vulnerable population not selected. Exclusion criterion: 'Persons deprived of liberty or under guardianship or incapable of giving consent'. Trial enrols capable adult participants only (no children); incapable persons are excluded and informed consent from capable adult participants is required.
Inclusion criteria
- {"criterion_text":"- Histologically proven squamous cell carcinoma of the esophagus (ESCC)\n- Metastatic or locally advanced cancer\n- Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting\n- Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician\n- At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria\n- Patients ≥ 70 years\n- Subjects with WHO performance status ≤ 2"}
Exclusion criteria
- {"criterion_text":"- History of another primary malignancy\n- Persons deprived of liberty or under guardianship or incapable of giving consent\n- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator\n- History of allogenic organ, bone marrow, or double umbilical cord blood transplantation\n- Active documented autoimmune or inflammatory disorders\n- Previous immune checkpoint inhibitor therapy within the 2 years before inclusion\n- Patients with evidence of fistula (either oesophageal/bronchial or oesophageal/aorta)\n- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML\n- Patient with symptomatic central nervous system (CNS) metastases\n- History of active primary immunodeficiency"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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).","definition_or_measurement_approach":"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."}
Secondary endpoints
- {"endpoint_text":"- •\tSafety according to NCI-CTCAE version 5.0\n- •\tOverall survival (OS) at 6 months depending on PD-L1 expression\n- •\tOverall response rate (ORR) according to RECIST 1.1 criteria\n- •\tProgression-free survival (PFS) at 3 and 6 months according to RECIST 1.1 criteria and depending on PDL1 expression\n- •\tPatients’ health-related quality of life (EORTC QLQC30, OES-18 and QLQ-ELD14 scales)\n- •\tOS and PFS according to geriatric parameters (complete G-CODE, and ADL and IADL sub-scales)\n- •\tPrognostic value of immune biomarkers","definition_or_measurement_approach":"Safety assessed by NCI-CTCAE v5.0; OS measured at 6 months and analyzed by PD-L1 expression; ORR assessed per RECIST 1.1; PFS at 3 and 6 months per RECIST 1.1 and by PD-L1 expression; quality of life measured with EORTC QLQC30, OES-18 and QLQ-ELD14; OS and PFS also analyzed according to geriatric parameters (G-CODE, ADL, IADL); evaluation of prognostic/immune biomarkers using baseline biomarker data."}
Recruitment
- Planned Sample Size
- 95
- Recruitment Window Months
- 54
- Consent Approach
- Informed consent obtained from capable adult participants. Subject information and informed consent form documents titled 'L1_SIS and ICF adults' are available (for adults). Persons incapable of giving consent are excluded. No paediatric assent (no children included). Languages of consent documents not specified.
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 95
France
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 17-04-2025
- Processing Time Days
- 6
- Number Of Sites
- 30
- Number Of Participants
- 95
Sites
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Hepatogastroenterology
- Principal Investigator Name
- Franck AUDEMAR
- Principal Investigator Email
- faudemar@ch-ccotebasque.fr
- Contact Person Name
- Franck AUDEMAR
- Contact Person Email
- faudemar@ch-ccotebasque.fr
- Site Name
- CHU Besancon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Angélique VIENOT
- Principal Investigator Email
- A3vienot@chu-besancon.fr
- Contact Person Name
- Angélique VIENOT
- Contact Person Email
- A3vienot@chu-besancon.fr
- Site Name
- Groupe Hospitalier Rance Emeraude
- Department Name
- Hépato-Gastro-Entérologie
- Principal Investigator Name
- Anaïs BODERE
- Principal Investigator Email
- anais.bodere@ch-dinan.fr
- Contact Person Name
- Anaïs BODERE
- Contact Person Email
- anais.bodere@ch-dinan.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Clélia COUTZAC
- Principal Investigator Email
- clelia.coutzac@lyon.unicancer.fr
- Contact Person Name
- Clélia COUTZAC
- Contact Person Email
- clelia.coutzac@lyon.unicancer.fr
- Site Name
- Scp Institut De Cancerologie Des Hauts De France
- Department Name
- On
- Principal Investigator Name
- Laurent BASSON
- Principal Investigator Email
- laurent.basson@ichf.fr
- Contact Person Name
- Laurent BASSON
- Contact Person Email
- laurent.basson@ichf.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Digestive Surgery and Oncology
- Principal Investigator Name
- Marine JARY
- Principal Investigator Email
- mjary@chu-clermontferrand.fr
- Contact Person Name
- Marine JARY
- Contact Person Email
- mjary@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Gastroenterologie
- Principal Investigator Name
- Olivier BOUCHE
- Principal Investigator Email
- obouche@chu-reims.fr
- Contact Person Name
- Olivier BOUCHE
- Contact Person Email
- obouche@chu-reims.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Oncologic department
- Principal Investigator Name
- Frédéric THUILLIER
- Principal Investigator Email
- frederic.thuillier@chu-limoges.fr
- Contact Person Name
- Frédéric THUILLIER
- Contact Person Email
- frederic.thuillier@chu-limoges.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Medical oncology
- Principal Investigator Name
- May MABRO
- Principal Investigator Email
- m.mabro@isc84.org
- Contact Person Name
- May MABRO
- Contact Person Email
- m.mabro@isc84.org
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Gastro-enterology and Medical ONCOLOGY
- Principal Investigator Name
- David TOUGERON
- Principal Investigator Email
- david.tougeron@chu-poitiers.fr
- Contact Person Name
- David TOUGERON
- Contact Person Email
- david.tougeron@chu-poitiers.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Gastroenterology
- Principal Investigator Name
- Thomas Aparicio
- Principal Investigator Email
- thomas.aparicio@aphp.fr
- Contact Person Name
- Thomas Aparicio
- Contact Person Email
- thomas.aparicio@aphp.fr
- Site Name
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Olivier DUBREUIL
- Principal Investigator Email
- odubreuil@hopital-dcss.org
- Contact Person Name
- Olivier DUBREUIL
- Contact Person Email
- odubreuil@hopital-dcss.org
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Hepato-gastroenterology and Digestive oncology
- Principal Investigator Name
- Vincent HAUTEFEUILLE
- Principal Investigator Email
- hautefeuille.vincent@chu-amiens.fr
- Contact Person Name
- Vincent HAUTEFEUILLE
- Contact Person Email
- hautefeuille.vincent@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service des maladies de l'appareil digestif
- Principal Investigator Name
- Astrid LIEVRE
- Principal Investigator Email
- astrid.lievre@chu-rennes.fr
- Contact Person Name
- Astrid LIEVRE
- Contact Person Email
- astrid.lievre@chu-rennes.fr
- Site Name
- Hopital Prive Jean Mermoz
- Department Name
- Hépato-Gastro-Entérologie
- Principal Investigator Name
- Matthieu SARABI
- Principal Investigator Email
- matthieu.sabari@gmail.com
- Contact Person Name
- Matthieu SARABI
- Contact Person Email
- matthieu.sabari@gmail.com
- Site Name
- CHRU De Nancy
- Department Name
- gastroenterology
- Principal Investigator Name
- Marie MULLER
- Principal Investigator Email
- m.muller7@chru-nancy.fr
- Contact Person Name
- Marie MULLER
- Contact Person Email
- m.muller7@chru-nancy.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncology
- Principal Investigator Name
- Jean-Philippes METGES
- Principal Investigator Email
- jean-philippe.metges@chu-brest.fr
- Contact Person Name
- Jean-Philippes METGES
- Contact Person Email
- jean-philippe.metges@chu-brest.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hepatogastroenterology
- Principal Investigator Name
- Thierry LECOMTE
- Principal Investigator Email
- thierry.lecomte@med.univ-tours.fr
- Contact Person Name
- Thierry LECOMTE
- Contact Person Email
- thierry.lecomte@med.univ-tours.fr
- Site Name
- Centre Hospitalier Bethune Beuvry
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hélène VAN DAMME
- Principal Investigator Email
- hvandamme@ch-bethune.fr
- Contact Person Name
- Hélène VAN DAMME
- Contact Person Email
- hvandamme@ch-bethune.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- HepatoGastroenterology
- Principal Investigator Name
- Frédéric DI FIORI
- Principal Investigator Email
- frederic.di-fiore@chu-rouen.fr
- Contact Person Name
- Frédéric DI FIORI
- Contact Person Email
- frederic.di-fiore@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Oncology
- Principal Investigator Name
- Sylvain MANFREDI
- Principal Investigator Email
- sylvain.manfredi@chu-dijon.fr
- Contact Person Name
- Sylvain MANFREDI
- Contact Person Email
- sylvain.manfredi@chu-dijon.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aurélie Parzy
- Principal Investigator Email
- a.parzy@baclesse.unicancer.fr
- Contact Person Name
- Aurélie Parzy
- Contact Person Email
- a.parzy@baclesse.unicancer.fr
- Site Name
- Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- hélène FLESCH
- Principal Investigator Email
- josephine.lemaitre@chu-lille.fr
- Contact Person Name
- hélène FLESCH
- Contact Person Email
- josephine.lemaitre@chu-lille.fr
- Site Name
- Hopital Europeen Georges Pompidou
- Department Name
- Digestive Oncology
- Principal Investigator Name
- AZIZ ZANAAN
- Principal Investigator Email
- olivier.pellerin@egp.aphp.fr
- Contact Person Name
- AZIZ ZANAAN
- Contact Person Email
- olivier.pellerin@egp.aphp.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Medical Oncology
- Principal Investigator Name
- Meher BEN ABDELGHANI
- Principal Investigator Email
- m.ben-abdelghani@icans.eu
- Contact Person Name
- Meher BEN ABDELGHANI
- Contact Person Email
- m.ben-abdelghani@icans.eu
- Site Name
- Institut Godinot
- Department Name
- Medical Oncology
- Principal Investigator Name
- Damien BOTSEN
- Principal Investigator Email
- damien.botsen@reims.unicancer.fr
- Contact Person Name
- Damien BOTSEN
- Contact Person Email
- damien.botsen@reims.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Joséphine LEMAITRE
- Principal Investigator Email
- josephine.lemaitre@chu-lille.fr
- Contact Person Name
- Joséphine LEMAITRE
- Contact Person Email
- josephine.lemaitre@chu-lille.fr
- Site Name
- Centre Hospitalier Annecy Genevois
- Department Name
- Hépato Gastro Entérologie
- Principal Investigator Name
- MONTCHAUD Aude
- Principal Investigator Email
- amontchaud@ch-annecygenevois.fr
- Contact Person Name
- MONTCHAUD Aude
- Contact Person Email
- amontchaud@ch-annecygenevois.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical oncology
- Principal Investigator Name
- Judith RAIMBOURG
- Principal Investigator Email
- judith.raimbourg@ico.unicancer.fr
- Contact Person Name
- Judith RAIMBOURG
- Contact Person Email
- judith.raimbourg@ico.unicancer.fr
- Site Name
- Centre Hospitalier De Perpignan
- Department Name
- HepatoGastroEnterologie
- Principal Investigator Name
- Faiza KHEMISSA AKOUZ
- Principal Investigator Email
- faiza.khemissa@ch-perpignan.fr
- Contact Person Name
- Faiza KHEMISSA AKOUZ
- Contact Person Email
- faiza.khemissa@ch-perpignan.fr
Sponsor
Primary sponsor
- Full Name
- University Hospital Of Clermont-Ferrand
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Tevimbra 100 mg concentrate for solution for infusion
- Active Substance
- Tislelizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation EU/1/23/1758/001 (authorised)
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg
- Maximum Dose
- 200 mg (max daily); max total dose amount recorded 6800 mg
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)