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SAFE-ESO_Phase II study evaluating safety and efficacy of Tislelizumab for elderly patients unfit for chemotherapy, with advanced esophageal squamous-cell carcinoma
EU CTIS ID: 2024-518358-17-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven squamous cell carcinoma of the esophagus (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
You likely can't join if
- History of another primary malignancy
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
- History of allogenic organ, bone marrow, or double umbilical cord blood transplantation
- Active documented autoimmune or inflammatory disorders
- Previous immune checkpoint inhibitor therapy within the 2 years before inclusion
See the full eligibility criteria
- Histologically proven squamous cell carcinoma of the esophagus (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
- History of another primary malignancy
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
- History of allogenic organ, bone marrow, or double umbilical cord blood transplantation
- Active documented autoimmune or inflammatory disorders
- Previous immune checkpoint inhibitor therapy within the 2 years before inclusion
- Patients with evidence of fistula (either oesophageal/bronchial or oesophageal/aorta)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.