Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Exclusion Criteria

• •Other malignant tumors within 5 years prior to the start of this study;
• •High risk of gastrointestinal bleeding, esophageal fistula or perforation;
• •Unrelieved toxic reactions of grade ≥ 1(excluding alopecia and fatigue; hematological toxicity must be recovered to grade ≤1 or baseline before enrollment);
• •Weight loss of ≥20% within 90 days prior to signing the informed consent form;
• •Poor nutritional status or a PG-SGA score of ≥9;
• •Any severe and/or uncontrolled diseases. This includes:
• •1. Uncontrolled blood pressure (systolic pressure ≥150mmHg or diastolic pressure ≥100mmHg);
• •2. Suffering from grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥470ms), and grade ≥2 congestive heart failure (New York Heart Association \[NYHA\] classification);
• •3. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases;
• •4. Active or uncontrolled severe infections (grade ≥2 CTCAE infections);
• •5. Liver cirrhosis, active hepatitis; active hepatitis (for hepatitis B: positive HBsAg and HBV DNA levels exceeding the upper limit of normal; for hepatitis C: positive HCV antibodies and HCV viral load exceeding the upper limit of normal);
• •6. Active syphilis;
• •7. Renal failure requiring hemodialysis or peritoneal dialysis;
• •8. A history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• •Poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10mmol/L);
• •Major surgical treatment, incisional biopsy, or significant traumatic injury within 60 days before the start of the study; or long-term unhealed wounds or fractures;
• •Serious arterial/venous thrombotic events within 6 months before the start of the study, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
• •A history of substance abuse and inability to quit or with mental disorders;
• •Tumor-related symptoms and treatments:
• •1. Thoracic radiotherapy;
• •2. Traditional Chinese medicine drugs approved by the NMPA with clear anti-tumor indications in the drug instructions within 2 weeks before the start of the study (including Compound Esophageal Cancer Capsules, Kangai Injection, Kanglaite Capsules/Injection, Aidi Injection, Bitternut Oil Injection/Capsules, Xiaoai Ping Tablets/Injection, Huachansu Capsules, etc.);
• •3. Uncontrollable, repeatedly drained pleural effusion, pericardial effusion, or ascites (investigator's judgment);
• •4. Central nervous system metastasis and/or meningeal carcinomatosis;
• •Study treatment-related:
• •1. History of attenuated live vaccine administration within 14 days before the start of the study or plans for attenuated live vaccine administration during the study;
• •2. Severe hypersensitivity reactions after the use of monoclonal antibodies;
• •3. Active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the start of the study, excluding replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency);
• •4. Immunodeficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy (dose \>10mg/day prednisone or other equivalent hormones) and still in use within 2 weeks of the first administration;
• •5. A history of active tuberculosis;
• •Participation in other clinical studies within 4 weeks before the start of the study;
• •A history of severe allergies;
• •Allergic to the active ingredients or excipients of the study drugs, such as camrelizumab, paclitaxel, carboplatin, etc.;