OncoMatch/Clinical Trials/NCT07205731
Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma
Is NCT07205731 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1 for esophageal squamous cell carcinoma (escc).
Treatment: Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1 — 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 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Performance status
WHO 0–2
Prior therapy
Cannot have received: immunotherapy
Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
Cannot have received: chemotherapy
Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
Cannot have received: radiotherapy
Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
Cannot have received: platinum-based chemotherapy
Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician
Cannot have received: immune checkpoint inhibitor
Previous immune checkpoint inhibitor therapy within the 2 years before inclusion
Cannot have received: chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies
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
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1 × 10^9/L, Platelet count ≥ 75 × 10^9/L, Hemoglobin ≥ 90 g/L
Kidney function
Measured creatinine clearance (CL) > 40 mL/min (MDRD method)
Liver function
AST and 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
Adequate marrow and organ functions defined as: Absolute neutrophil count (ANC) ≥ 1 × 10^9/L, Platelet count ≥ 75 × 10^9/L, Hemoglobin ≥ 90 g/L, AST and 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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