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Esophageal Squamous Cell Carcinoma (ESCC)Phase 2SAFE ESONCT07205731

Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma

A Phase 2 study testing Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1 in people with Esophageal Squamous Cell Carcinoma (ESCC), run by University Hospital, Clermont-Ferrand at 30 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
30 sitesFrance
Study dates
7 Oct 2025to Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
  • At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria
  • Patients ≥ 70 years
Show all 20Show fewer
  • Subjects with WHO performance status ≤ 2
  • Estimated life expectancy >3 months
  • Adjuvant therapy finished >6 months
  • Adequate marrow and organ functions defined as:
  • Absolute neutrophil count (ANC) ≥ 1 × 109/L,
  • Platelet count ≥ 75 × 109/L,
  • Hemoglobin ≥ 90 g/L,
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN, or AST and ALT ≤5 ×ULN for patients with liver metastases
  • ALP ≤ 5 x ULN unless liver metastases are present, in which case it must be ≤ 10x ULN
  • Measured creatinine clearance (CL) > 40 mL/min (MDRD method)
  • Male patients must use a condom during treatment and for 6 months after the last dose when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential during treatment and for 6 months after the last dose.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up.
  • Signed written informed consent obtained prior to any study specific procedures
  • Patient affiliated to a social security scheme

Who cannot join

  • History of another primary malignancy. May be included, patients with:
  • 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
  • Participation in another clinical study with an investigational product during the last 2 months.
Show all 35Show fewer
  • Concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • History of allogenic organ, bone marrow, or double umbilical cord blood transplantation
  • Active documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). May be included:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
  • Any chronic skin condition that does not require systemic therapy.
  • Patients with celiac disease controlled by diet alone
  • Previous immune checkpoint inhibitor therapy within the 2 years before inclusion
  • Uncontrolled intercurrent illness; uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (recurrence ≤ 14 days after intervention). Patients with the following diseases are not excluded and may proceed to further screening:
  • Controlled Type I diabetes
  • Hypothyroidism (provided it is managed with hormone replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
  • Any other disease that is not expected to recur in the absence of external triggering factors
  • Patients with evidence of fistula (either oesophageal/bronchial or oesophageal/aorta)
  • Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, pulmonary embolism/deep vein thrombosis, cerebrovascular accident, and heart failure, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, interstitial bilateral lung disease on high Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or might impair compliance with study conduct. A history of severe hypersensitivity reactions to other monoclonal antibodies. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is shorter) of the first study drug administration.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
  • Patient with symptomatic central nervous system (CNS) metastases.
  • History of active primary immunodeficiency.
  • Known non-controlled serologically positive human immunodeficiency virus (HIV) patients with CD4 < 400 / mm3.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), active untreated hepatitis B (known positive HBV surface antigen (HBsAg) result), active untreated hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of -immunotherapy. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI
  • Follow-up impossible, according to investigator's decision
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
  • Persons i) deprived of liberty by judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research, and (ii) adults subject to a legal protection measure or unable to express their consent (Article L1121-8)

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Laclautre contact

0473754963

promo_interne_drci@chu-clermontferrand.fr

30 sites in 1 country

France30 sites, 30 recruiting

  • CHU Amiens

    Amiens

    Vincent HAUTEFEUILLE

    Not yet recruiting

  • Centre Hospitalier Annecy Genevois

    Annecy, Epagny Metz-Tessy, 74370

    Aude Montchaud

    Not yet recruiting

  • Institut régional du cancer Provence d'Avignon

    Avignon

    May MABRO

    Not yet recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

    Franck Audemar

    Not yet recruiting

  • CHU Besançon

    Besançon

    Angélique VIENOT

    Recruiting

  • CH Béthune et Beuvry

    Beuvry

    Hélène VAN DAMME

    Recruiting

  • ICHF Centre Pierre Curie

    Beuvry

    BASSON Laurent

    Recruiting

  • CHRU Brest

    Brest

    Jean-Philippes METGES

    Recruiting

  • Centre François Baclesse

    Caen

    Aurélie PARZY

    Recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand

    Lise LACLAUTRE

    Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr

    Not yet recruiting

  • CHU Dijon

    Dijon

    Sylvain MANFREDI

    Not yet recruiting

  • Groupe Hospitalier Mutualiste

    Grenoble

    Hélène FLESCH

    Not yet recruiting

  • CHRU Lille

    Lille

    Anthony TURPIN

    Recruiting

  • CHU Limoges

    Limoges

    Frédéric THUILLIER

    Not yet recruiting

  • Centre Léon BERARD de Lyon

    Lyon

    Clélia COUTZAC

    Not yet recruiting

  • CHU Nancy

    Nancy

    Marie MULLER

    Recruiting

  • Hôpital Européen Georges-Pompidou

    Paris

    Aziz ZANAAN

    Recruiting

  • Hôpital Saint-Louis Lariboisière

    Paris

    Thomas APARICIO

    Recruiting

  • Le Groupe Hospitalier Diaconesses Croix Saint-Simon de Paris

    Paris

    Olivier DUBREUIL

    Recruiting

  • Centre hospitalier de Perpignan

    Perpignan

    Faiza KHEMISSA AKOUZ

    Not yet recruiting

  • CHU Poitiers

    Poitiers

    David TOUGERON

    Recruiting

  • Centre Régional du Lutte Contre Le Cancer - Institut Godinot

    Reims, 51726

    Damien BOTSEN

    Not yet recruiting

  • CHU de Reims

    Reims

    Olivier BOUCHE

    Not yet recruiting

  • CHU Rennes

    Rennes

    Astrid LIEVRE

    Recruiting

  • CHU Rouen

    Rouen

    Frédéric DI FIORE

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

    Judith RAIMBOURG

    Recruiting

  • Groupe Hospitalier Rance Emeraude

    St-Malo

    Anaïs BODERE

    Recruiting

  • Institut Public de Cancérologie Strauss Europe,

    Strasbourg

    Meher BEN ABDELGHANI

    Not yet recruiting

  • CHRU Tours

    Tours

    Thierry LECOMTE

    Not yet recruiting

  • Médipôle Hôpital Mutualiste

    Villeurbanne

    Matthieu SARABI

    Recruiting

Other trials in France

About this study

Official title: PRODIGE 102 - FFCD 2201 - SAFE-ESO Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma

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

Read more

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
Read the detailed description

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.

Being tested
Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1
Keywords
digestive oncology, immunotherapy, microenvironment biomarker, oncology, oncogeriatric domain, Ederly patients, chemotherapy
Medical subject headings
Esophageal Squamous Cell Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1Drug

    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

Study groups in NCT07205731
Study groupRoleWhat they receive
all patients receive the Tislelizumab on monotherapyExperimentalNot described
Receives: Drug: Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 month after inclusion

Secondary outcomes (9)

  1. 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

    Measured: time between the date of the first dose treatment with tislelizumab and the date within the 90 days after the last dose of treatment

  2. - 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

    Measured: 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

  3. - 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.

    Measured: the time between the date of the first dose treatment with tislelizumab and the date of last dose of treatment

  4. 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.

    Measured: at 3 month and 6 month after inclusion

  5. 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

    Measured: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment

  6. 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

    Measured: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment

  7. 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

    Measured: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment

  8. 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

    Measured: time between the date of the first dose treatment with tislelizumab and the date within the 30 days after the last dose of treatment

  9. 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.

    Measured: the time between the date of the first dose treatment with tislelizumab and the first radiological tumoral evaluation at 9 weeks after C1J1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start7 Oct 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205731
Sponsor's protocol ID
PHRC K 2023 JARY
Acronym
SAFE ESO
Status last verified
May 2026
First submitted
12 Sep 2025
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1 in people with Esophageal Squamous Cell Carcinoma (ESCC), run by University Hospital, Clermont-Ferrand at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 month after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07205731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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