Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Exclusion Criteria

• •1. History of other malignancies;
• •2. History of fistula caused by primary tumor infiltration;
• •3. Patients at high risk of esophageal fistula or with signs of esophageal perforation;
• •4. History of esophageal cancer surgery;
• •5. Poor nutritional status, with BMI less than 18.5 kg/m², or PG-SGA score ≥ 9;
• •6. Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to randomization);
• •7. Known intolerance or resistance to the chemotherapy regimen specified in the study protocol;
• •8. Prior receipt of any other anti-tumor therapy for ESCC (e.g., therapies targeting PD-1, PD-L1, PD-L2, or other tumor immunotherapies, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);
• •9. Patients with active autoimmune disease or a history of autoimmune disease that may relapse;
• •10. Note: Patients with the following conditions are not excluded and may proceed to further screening:
• •a. Controlled type I diabetes; b. Hypothyroidism (controlled with hormone replacement therapy only); c. Controlled celiac disease; d. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease that is not expected to relapse in the absence of external triggers; k. Presence of other active malignancies within ≤ 2 years prior to enrollment, except for the specific cancer under study in this trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast); l. Any condition requiring systemic treatment with corticosteroids (dose \> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within ≤ 14 days prior to randomization;
• •Note: Patients who have currently or previously used any of the following steroid regimens are not excluded:
• •a. Adrenal replacement steroids (prednisone ≤ 10 mg/day or equivalent); b. Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; c. Short-term (≤ 7 days) prophylactic use of corticosteroids (e.g., for prevention of contrast agent allergy) or for treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reaction caused by contact allergens); m. Presence of uncontrolled diabetes, laboratory test abnormalities for potassium or sodium \> Grade 1 despite standard medical therapy, or hypoalbuminemia ≥ Grade 3 within ≤ 14 days prior to enrollment; n. History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases including pulmonary fibrosis, acute lung diseases, etc.; o. Presence of severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy (including tuberculosis infection, etc.) within 14 days prior to enrollment; Note: Patients with chronic HBV or HCV infection are permitted to receive antiviral therapy; p. Known history of HIV infection; q. Major surgery performed within ≤ 28 days prior to enrollment; Note: Minimally invasive procedures (e.g., peripherally inserted central catheter \[PICC\]) are not considered major surgery; r. Prior allogeneic stem cell transplantation or organ transplantation; s. Presence of any of the following cardiovascular risk factors:
• •1. Cardiac chest pain occurring within ≤ 28 days prior to randomization, defined as moderate pain limiting instrumental activities of daily living;
• •2. Symptomatic pulmonary embolism occurring within ≤ 28 days prior to randomization;
• •3. Acute myocardial infarction occurring within ≤ 6 months prior to randomization;
• •4. History of heart failure reaching New York Heart Association (NYHA) Class III or IV within ≤ 6 months prior to randomization;
• •5. Ventricular arrhythmia ≥ Grade 2 occurring within ≤ 6 months prior to randomization;
• •6. Cerebrovascular accident occurring within ≤ 6 months prior to randomization;
• •7. Uncontrolled hypertension despite antihypertensive medication, i.e., systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, within ≤ 28 days prior to randomization;
• •8. Syncope or seizure occurring within ≤ 28 days prior to randomization;
• •t. History of severe hypersensitivity reaction to other monoclonal antibodies or to cisplatin or paclitaxel; u. Receipt of any chemotherapy, immunotherapy (e.g., interleukins, interferons, thymosins, etc.), or any investigational treatment within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; v. Use of herbal medicines for cancer control within 14 days prior to the first dose of study drug; w. Patients with toxicities from prior anti-tumor therapy that have not recovered to baseline or stable levels, unless considered as adverse events without safety risks (e.g., alopecia, neuropathy, specific laboratory abnormalities); x. Receipt of live vaccine within ≤ 28 days prior to randomization; Note: Seasonal influenza vaccines are typically inactivated vaccines and are permitted. Intranasal vaccines are live vaccines and are not permitted; y. Presence of underlying diseases (including laboratory abnormalities), alcohol or substance abuse or dependence that may interfere with study drug administration, affect interpretation of drug toxicity or adverse events, or compromise the patient's compliance with study procedures; z. Concurrent participation in another therapeutic clinical trial; aa. Other factors that, in the investigator's judgment, may necessitate premature termination of the study participation (e.g., prisoners or individuals under involuntary detention; individuals detained involuntarily for treatment of psychiatric or physical illnesses such as infectious diseases).