Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial

Prior treatment

• Patients with existing or concurrent hemorrhagic disorders;
• Patients who have used immunosuppressive agents prior to enrollment due to comorbid conditions, with a dose equivalent to ≥10mg/day of oral prednisone sustained for more than 2 weeks;
• Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe pulmonary impairment, etc.;

Other illness

• Patients with double primary cancers;
• Patients with infections requiring treatment;
• Patients requiring continuous systemic corticosteroid therapy (Note: Replacement therapy (e.g., for thyroid insufficiency, insulin therapy, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy and is permitted);
• Patients with unstable angina within 3 months or myocardial infarction within 6 months;
• Patients with psychiatric disorders;
• Patients with autoimmune diseases, immunodeficiency, or organ transplantation;
• Patients with active Hepatitis B or Hepatitis C infection.

Lab values

• Patients with abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5g/L), bleeding tendency, or those receiving thrombolytic or anticoagulant therapy;

Other

• Female patients who are pregnant or breastfeeding;
• Patients with bronchial asthma requiring intermittent use of bronchodilators or medical intervention;

• Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
• Initial patients are those with resectable or potentially resectable (T1 N1-3 M0 or T2-3 N0-3 M0) thoracic segment esophageal squamous cell carcinoma (8th UICC-TNM staging); who have undergone surgical resection after 2 cycles of immunotherapy combined with chemotherapy and achieved R0 resection.
• Age 18 to 75 years.
• Preoperative examinations of various organ functions indicate no surgical contraindications.
• The following laboratory tests confirm that bone marrow, liver, and kidney functions meet the study requirements:
  • Hemoglobin ≥ 90 g/L; White blood cell count ≥ 4.0 × 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 times ULN; International normalized ratio (INR) of prothrombin time ≤ 1.5 times ULN, and activated partial thromboplastin time within the normal range; Creatinine ≤ 1.5 times ULN.
• No postoperative chemotherapy, radiotherapy, or hormone therapy for malignant tumors has been administered; no history of other malignancies, excluding prostate cancer patients who have received hormone therapy and achieved disease-free survival (DFS) for over 5 years.
• Physical status ECOG score 0 to 1.
• Women of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after study completion; serum or urine pregnancy test within 7 days before study enrollment must be negative, and patients must be non-lactating; men must agree to use contraceptive measures during the study and for 6 months after study completion.