The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.
Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;
The age of signing ICF is ≥ 18 years old and ≤ 75 years old;
Esophageal Squamous Cell Carcinoma (ESCC) confirmed by histopathology or cytology;
Patients with advanced esophageal squamous cell carcinoma who have failed or are intolerant to prior first-line standard therapy (for patients with PD-L1 expression positive [CPS ≥1], first-line standard therapy is defined as platinum-based chemotherapy and immune checkpoint inhibitor [ICI] therapy; for patients with PD-L1 expression negative [CPS <1], first-line standard therapy is defined as platinum-based chemotherapy). Intolerable toxicity refers to the occurrence of CTCAE grade ≥3 adverse events.;
History of any second malignant tumor within the first 2 years prior to randomization;
BMI <17.5 kg/m2；
Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;
After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;