Qiandongnan Miao And Dong Autonomous Prefecture

Researchers are evaluating the safety and effectiveness of TQB6411 Injection in adults aged 18 to 75 years with recurrent or metastatic esophageal cancer who have not responded to previous treatment with PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy. This study includes Phase Ib to assess tolerance and safety, and Phase II to evaluate how well the treatment works in this patient group. TQB6411 Injection is an antibody-drug conjugate targeting EGFR and c-Met. Participants receive TQB6411 Injection administered as part of the study treatment. The trial includes a dose-finding phase to determine the recommended Phase 2 dose over 3 months, followed by ongoing treatment and observation for up to 24 months. During this time, researchers monitor adverse events and progression-free survival to assess safety and efficacy. Throughout the study, participants undergo regular evaluations including laboratory tests, tumor assessments based on measurable lesions, and biomarker analysis from tumor tissue samples. Safety is closely monitored with attention to adverse events and treatment compliance. The total study duration for each participant may be up to 24 months to capture long-term outcomes and side effects.