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Tislelizumab for people 70+ with advanced esophageal squamous-cell cancer who are unfit for chemotherapy

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

Phase 2 Interventional University Hospital, Clermont-Ferrand · NCT07205731

This trial will try the anti–PD-1 drug tislelizumab, given by IV every 3 weeks, as first-line treatment for people aged 70 and older with advanced esophageal squamous-cell carcinoma who cannot receive platinum chemotherapy to see how many are alive at 6 months.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment95 (estimated)
Ages70 Years and up
SexAll
SponsorUniversity Hospital, Clermont-Ferrand Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation, prednisone, Tislelizumab
Locations30 sites (Annecy, Epagny Metz-Tessy and 29 other locations)
Trial IDNCT07205731 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, single-arm Phase II trial enrolling patients aged 70 or older with metastatic or locally advanced esophageal squamous-cell carcinoma who are judged ineligible for platinum-based chemotherapy. Participants receive tislelizumab 200 mg by IV infusion every 3 weeks for up to 2 years or until disease progression or unacceptable toxicity. The study measures safety, overall survival at 6 months (with subgroup comparisons by PD-L1 status), objective response rate by imaging, progression-free survival at 3 and 6 months, health-related quality of life, and outcomes stratified by geriatric parameters, plus exploratory immune biomarker analyses. PD-L1 testing is performed centrally for ancillary analyses, and patients are included regardless of baseline PD-L1 expression.

Who should consider this trial

Good fit: Patients aged 70 or older with histologically proven metastatic or locally advanced ESCC, no prior first-line systemic therapy, judged ineligible for platinum-based chemotherapy, WHO performance status ≤2, life expectancy >3 months, and adequate organ and marrow function are eligible.

Not a fit: Patients who are fit for standard platinum-based regimens, those with very poor organ function or rapidly progressive disease, or those with contraindications to PD-1 blockade are less likely to benefit from this approach.

Why it matters

Potential benefit: If successful, the treatment could offer a tolerable immunotherapy option that improves short-term survival and quality of life for elderly patients who cannot receive standard platinum chemotherapy.

How similar studies have performed: Other PD-1 inhibitors such as pembrolizumab and nivolumab have shown clinical benefit in esophageal squamous-cell carcinoma, so the approach has precedent though first-line monotherapy specifically in chemo-unfit elderly patients has limited direct evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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.
* 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)

Where this trial is running

Annecy, Epagny Metz-Tessy and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Esophageal Squamous Cell Carcinomadigestive oncologyimmunotherapymicroenvironment biomarkeroncologyoncogeriatric domainEderly patientschemotherapy
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.