AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC

Exclusion Criteria

• •1. Locally advanced esophageal cancer that can be radically resectable or potentially cured by radiotherapy
• •2. Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
• •3. Symptomatic central nervous system metastases (brain metastases confirmed stable by imaging for more than 3 months can be enrolled)
• •4. A serious infection (CTCAE \> grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious comorbidities that occurred within 4 weeks prior to the first administration of the study drug; baseline chest imaging suggestive of active pulmonary inflammation with clinically relevant signs or symptoms; signs and symptoms of infection within 2 weeks prior to the first administration of study drug, or requiring oral, or intravenous antibiotic therapy. Excluding prophylactic use of antibiotics
• •5. Patients with previous and current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with radiation pneumonia within 6 months
• •6. Patients with active tuberculosis infection detected by history or CT examination, patients with a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment
• •7. Patients previously treated with immune checkpoint inhibitors
• •8. Patients who have a congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection of the assay) or combined hepatitis B and hepatitis C co-infection
• •9. Patients who have a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• •10. The presence of thrombosis-type diseases or using anticoagulant drugs
• •11. Patients with any serious or uncontrolled systemic disease that, in the opinion of the investigator, may increase the risk associated with participation