Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.

Exclusion Criteria

• •1. patients with an untreated diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ)
• •2. patients at risk for tracheoesophageal fistula or aortoesophageal fistula
• •3. currently participating in an interventional clinical study treatment or have received another study drug or been treated with an investigational device within 4 weeks prior to the first dose
• •4. have received prior therapy with: an anti-PD-1, anti-PD-L1 or anti-PD-L2 drug or a drug targeting another stimulatory or co-suppressive T-cell receptor (e.g., CTLA-4, OX-40, CD137).
• •5. systemic systemic therapy with a proprietary Chinese medicine or immunomodulatory agent (including thymidine, interferon, interleukin, except for local use to control pleural fluid) with an antitumor indication within 2 weeks prior to the first dose.
• •6. active autoimmune disease requiring systemic therapy (e.g., with disease-relieving drugs, glucocorticoids, or immunosuppressive agents) that occurred within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
• •7. is receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study.
• •Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted.
• •8. known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
• •9. known hypersensitivity to the active ingredient or excipients of the investigational drug Camrelizumab;
• •10. those with multiple factors affecting oral drug administration (e.g., inability to swallow, post-gastrectomy, chronic diarrhea, and intestinal obstruction)
• •11. have not recovered sufficiently from toxicity and/or complications from any intervention prior to initiation of therapy (i.e., ≤ grade 1 or at baseline, excluding malaise or alopecia)
• •12. known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
• •13. live vaccination within 30 days prior to the first dose (Cycle 1, Day 1). Note: Injectable inactivated viral vaccine for seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal administration of live attenuated influenza vaccine is not permitted.
• •14. women who are pregnant or breastfeeding.
• •15. Presence of any serious or uncontrollable systemic disease, such as
• •1. Resting ECG with significant and severely symptomatic uncontrollable abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, second degree or greater heart block, ventricular arrhythmia or atrial fibrillation.
• •2. Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) classification ≥ 2.
• •3. myocardial infarction within 6 months prior to randomization
• •4. suboptimal blood pressure control (systolic blood pressure \> 140 mmHg and diastolic blood pressure \> 90 mmHg)
• •5. history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first dose, or current clinically active interstitial lung disease.
• •6. active pulmonary tuberculosis.
• •7. the presence of an active or uncontrolled infection requiring systemic therapy
• •8. presence of clinically active diverticulitis, abdominal abscesses, gastrointestinal obstruction
• •9. the presence of liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
• •10. poorly controlled diabetes mellitus (fasting blood glucose (FBG) \> 10 mmol/L)
• •11. urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification \>1.0 g
• •12. patients with mental disorders and unable to cooperate with treatment
• •16. have a medical history or evidence of disease that may interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The investigator considers that there are other potential risks unsuitable for participation in this study.