Phase 3 Study Comparing YL201 to Chemotherapy in Adults With Advanced or Metastatic Esophageal Squamous Cell Carcinoma After First-Line Treatment Failure

What this Trial Is About

Researchers are evaluating a new medicine called YL201 compared to the standard chemotherapy chosen by doctors in people with locally advanced or metastatic esophageal squamous cell carcinoma who have stopped responding to first-line treatment. The goal is to see if YL201 works better and is safer. The study is a large, randomized phase III trial involving multiple hospitals and also investigates how YL201 is processed in the body, immune reactions it might cause, and whether certain biological markers can predict its effects. Participants will be assigned to one of two groups one group receives YL201 alone, given as an intravenous infusion on the first day of each 3-week cycle. The other group receives a chemotherapy drug chosen by their doctor, which may be paclitaxel, docetaxel, or irinotecan, each given intravenously on specific schedules every 3 weeks. The study treatment continues as planned, with monitoring throughout the treatment period. During the study, participants will undergo regular evaluations including scans and laboratory tests to measure how well the treatments are working and to monitor side effects. The main outcome researchers will track is overall survival for up to about 36 months. They will also assess progression-free survival, response rates, duration of response, and adverse events during this time. The study will last until the end of 2028, with ongoing monitoring and data collection.

A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy