SAFE-ESO_Phase II study evaluating safety and efficacy of Tislelizumab for elderly patients unfit for chemotherapy, with advanced esophageal squamous-cell carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 Oct 2025 → ongoing

Decision date (initial)

2025-04-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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 objectives 7

1. • Overall survival (OS)
2. • The Overall Response Rate (ORR)
3. Progression free survival (PFS)
4. • Patients’ health-related quality of life
5. Geriatric screening tools
6. Toxicity
7. - Biomarkers correlated with treatment efficacy (PFS and OS) and prognosis (using data from baseline):

Conditions and MedDRA coding

Squamous cell carcinoma of the esophagus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Histologically proven squamous cell carcinoma of the esophagus (ESCC)
2. Metastatic or locally advanced cancer
3. Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
4. Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician
5. At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria
6. Patients ≥ 70 years
7. Subjects with WHO performance status ≤ 2

Exclusion criteria 10

1. History of another primary malignancy
2. Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
3. History of allogenic organ, bone marrow, or double umbilical cord blood transplantation
4. Active documented autoimmune or inflammatory disorders
5. Previous immune checkpoint inhibitor therapy within the 2 years before inclusion
6. Patients with evidence of fistula (either oesophageal/bronchial or oesophageal/aorta)
7. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML
8. Patient with symptomatic central nervous system (CNS) metastases
9. History of active primary immunodeficiency
10. Persons deprived of liberty or under guardianship or incapable of giving consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 7

1. • Safety according to NCI-CTCAE version 5.0
2. • Overall survival (OS) at 6 months depending on PD-L1 expression
3. • Overall response rate (ORR) according to RECIST 1.1 criteria
4. • Progression-free survival (PFS) at 3 and 6 months according to RECIST 1.1 criteria and depending on PDL1 expression
5. • Patients’ health-related quality of life (EORTC QLQC30, OES-18 and QLQ-ELD14 scales)
6. • OS and PFS according to geriatric parameters (complete G-CODE, and ADL and IADL sub-scales)
7. • Prognostic value of immune biomarkers

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont-Ferrand

Postcode

63000

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Dr Marine JARY

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 30 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications