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 (Jun 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
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Performance status
WHO 0–2
Demographics
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.
Frequently asked questions
Is NCT07205731 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages