Phase II Study Evaluating Multiple Drug Combinations for Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating multiple drug combinations to treat advanced esophageal squamous cell carcinoma, focusing on patients who have experienced progression or intolerance to first-line chemotherapy or immunotherapy. The study aims to explore the safety and effectiveness of these treatments, especially for those who have developed resistance to immunotherapy, as current standard second-line treatments are limited. This phase II exploratory trial investigates different combinations to identify better therapy options for advanced esophageal cancer. The trial includes several treatment groups receiving combinations of drugs such as Apatinib with Camrelizumab or Adebrelimab, administered orally or by intravenous injection at specified doses and intervals. Participants are assigned to cohorts based on prior treatment history, with regimens designed for patients who have failed chemotherapy or immune checkpoint inhibitor therapies. The study drugs are given on schedules ranging from every two to three weeks, and the trial does not use randomization or blinding. Participants will undergo regular evaluations including imaging scans to measure tumor response, blood tests to assess organ function, and collection of tissue samples for biomarker analysis. Researchers will monitor objective response rates as the primary outcome over one year, along with secondary outcomes like disease control, survival rates, time to response, and safety over up to two years. The study requires participants to have good performance status and adequate organ function, with follow-up visits and safety assessments conducted throughout the study duration.

A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma