Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

Exclusion Criteria

• •Current or History of Other Malignancies
• •Subjects with any condition that may compromise venous access for drug administration or blood sampling are excluded.
• •Subjects with prior treatment-related adverse reactions that have not recovered to ≤ Grade 1 per CTCAE v5.0 criteria.
• •Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose, Scheduled major surgery during the study intervention period, Non-healing wound, ulcer, or bone fracture at screening
• •Subjects with any bleeding/hemorrhagic event ≥ Grade 3 (per CTCAE v5.0) occurring within 4 weeks before the first dose are excluded
• •History of Thromboembolic Events within 6 Months
• •Poorly Controlled Active Viral Hepatitis
• •Subjects with active syphilis infection requiring antimicrobial therapy are excluded
• •Subjects with any of the following pulmonary conditions are excluded: active tuberculosis, idiopathic pulmonary fibrosis (IPF), organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, symptomatic active pneumonia, or history of interstitial lung disease (ILD) requiring therapy
• •History of Substance Abuse or Psychiatric Disorders
• •History of Allogeneic Transplantation (Bone Marrow or Solid Organ)
• •History of Hepatic Encephalopathy
• •Major Cardiovascular Diseases
• •Active or Uncontrolled Severe Infections
• •Renal Failure Requiring Dialysis (Hemodialysis/Peritoneal Dialysis)
• •History of Immunodeficiency
• •Poorly Controlled Autoimmune Disease
• •Poorly Controlled Autoimmune Disease \& Epilepsy Requiring Treatment
• •Poorly Controlled Diabetes
• •Tumor-Related Symptoms and Treatment Considerations：
• •* Exclusion Criterion - Recent Anticancer Treatment (≤3 Weeks or Within 5 Half-Lives)
• •* Recent Use of National Medical Products Administration (NMPA) -Approved Anticancer Traditional Chinese Medicine (≤1 Week Prior to Treatment)
• •* Radiologically Confirmed Tumor Encasement of Major Vessels with High Bleeding Risk
• •* Uncontrolled Effusions Requiring Repeated Drainage
• •* Known to have spinal cord compression, leptomeningeal metastasis/carcinomatous meningitis, or symptomatic brain metastases with less than 4 weeks of symptom/imaging control.
• •Known Hypersensitivity to Investigational Drug or Excipients
• •Prior Treatment with Topoisomerase I Inhibitor-Based ADCs and/or Irinotecan Chemotherapy
• •Prior Participation in Anticancer Clinical Trials Within 4 Weeks
• •Investigator-Assessed Safety or Compliance Concerns