Phase II Study of Tislelizumab Monotherapy for Elderly Patients 70 and Older with Advanced Esophageal Squamous Cell Carcinoma Not Eligible for Chemotherapy

What this Trial Is About

Researchers are evaluating Tislelizumab as a first-line treatment for elderly patients aged 70 and above who have advanced esophageal squamous-cell carcinoma ESCC and are not eligible for platinum-based chemotherapy. This phase II, open-label study aims to assess the safety of Tislelizumab and its impact on overall survival at 6 months, considering PD-L1 protein expression on immune cells, along with other outcomes such as response rates, progression-free survival, quality of life, and immune biomarker prognostics. Participants will receive Tislelizumab, a monoclonal antibody targeting PD-1, administered by intravenous infusion at a dose of 200 mg every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity occurs, for a maximum duration of 2 years. Patients will be included regardless of PD-L1 status, with central comparisons made as part of ancillary analyses. During the study, participants will undergo regular assessments including imaging to evaluate tumor response, questionnaires to assess health-related quality of life, and geriatric evaluations. Safety will be monitored up to 90 days after the last dose. Researchers will measure overall survival at 6 months as the primary outcome, alongside secondary measures such as progression-free survival at 3 and 6 months, immune biomarker analysis, and comprehensive health evaluations throughout the treatment period and follow-up visits.

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