A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy

Korábbi kezelés

• Active bleeding or high risk of bleeding (as assessed by the investigator);
  • Patients requiring systemic anti-infective therapy;
  • Concurrent primary malignant tumors other than esophageal cancer (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Presence of brainstem, leptomeningeal metastasis, spinal cord metastasis, or compression;
  • Complicated with severe cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction within the past 5 years; and complicated with other uncontrolled acute or chronic diseases;
  • Positive for human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBsAg positive and HBV-DNA > 500 IU/ml or the upper limit of normal, whichever is higher), or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection);
  • Known allergy to any component of any study drug; known history of severe hypersensitivity reactions to other monoclonal antibodies; ⑧ Adverse reactions from prior immunotherapy not fully recovered;
  • Receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first study drug administration;
  • ⑩ Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to study administration. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
  • ⑪ Known history of mental illness, substance abuse, alcoholism, or drug addiction;
  • ⑫ Pregnant or breastfeeding women;
  • ⑬ Other conditions deemed unsuitable for participation in this study by the investigator, including but not limited to poor patient compliance, intolerance, etc.

• Age 18 to 75 years, male or female;
  • Histologically confirmed locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric junction;
  • ECOG performance status 0-1; ④ Failure of or local progression after 2-4 cycles of first-line chemotherapy combined with immunotherapy, or deemed unresectable by surgical evaluation;
  • ⑤ At least one measurable lesion according to RECIST v1.1 criteria;
  • ⑥ Adequate major organ and bone marrow function: Hematology: Hemoglobin (Hb) ≥90 g/L (without transfusion within 14 days); Absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN in cases of liver metastases); Total bilirubin (TBIL) ≤2×ULN; Serum albumin (ALB) ≥28 g/L; Serum creatinine (Cr) ≤1.5×ULN and creatinine clearance >50 μmol/L; Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy and INR and APTT are within the expected therapeutic range);
  • ⑦ Effective contraception during the study period;
  • Voluntary participation in this study with signed informed consent and good compliance.