drugset / Trial / NCT05919030
A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.
Timeline
- Start
- 2023-07-01
- Primary completion
- 2026-07-01
- Completion
- 2027-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 220 mg/m2 | Intravenous |
| Background | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |