Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer

Exclusion Criteria

• •Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;
• •Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;
• •Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE 5.0\]);
• •Subjects with any severe and/or uncontrolled disease. Including:
• •1. Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
• •2. Patients with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms) and ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification);
• •3. Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);
• •4. Cirrhosis, active hepatitis \* ; \* active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA test value more than the upper limit of normal; hepatitis C reference: HCV antibody positive, and HCV viral titer test value more than the upper limit of normal) ; patients with previous HBV infection or cured HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and the absence of HBsAg) are eligible; among patients with positive HCV antibody, patients can participate in this study only when HCV RNA is negative by polymerase chain reaction (PCR); Note: subjects with positive HBsAg or positive anti-HBc or hepatitis C，who are eligible for inclusion need continuous antiviral treatment to prevent virus activation ;
• •5. Previous (non infectious) pneumonia/interstitial lung disease still requires steroid treatment or currently has (non infectious) lung disease;
• •6. Active syphilis;
• •7. Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• •8. Patients with a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• •Poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L);
• •Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein \> 1.0g;
• •Patients who received major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment; or had wounds or fractures that were not healed for a long time;
• •Severe arterial/venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism within 6 months before the start of study treatment;
• •Patients who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
• •Study treatment related:
• •1. History of live vaccination 28 days prior to start of study treatment or planned live vaccination during the study;
• •2. Patients who have experienced severe hypersensitivity reactions after using monoclonal antibodies;
• •3. Active autoimmune disease requiring systemic therapy (eg, use of therapeutic drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to start of study treatment, with the exception of alternative therapies (eg, thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency);
• •4. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (prednisone at a dose \> 10 mg/day or other equivalent efficacy physiological dose hormone) and continued to use within 2 weeks before the first study dose;
• •5. Patients with a history of active tuberculosis;
• •Participating or participating in other clinical investigators;
• •Patients who are unable to comply with the trial protocol or cooperate with follow-up according to the investigator 's judgment;
• •Patients with a history of severe allergy;
• •Known hypersensitivity to active ingredients or excipients of the study drug, such as envafolimab and cisplatin;
• •Subjects who have concomitant diseases that, in the investigator 's judgment, would seriously jeopardize the subject' s safety or affect the completion of the study, or who are considered unsuitable for enrollment for other reasons.