A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma

Prior treatment

• 2.Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
• 6.Had undergone major surgery (except biopsy) within 4 weeks prior to randomization;
• 7.Had received a live vaccine within 4 weeks prior to the initial study drug treatment or planned to vaccinate during the study;
• 11.Conditions requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days before randomization；
• 18.Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;

Other illness

• 1.Cervical adenocarcinoma and rare pathological types of malignant tumors;
• 5.Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
• 8.Human immunodeficiency virus (HIV) infection;Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);
• 10.The presence of active or suspected autoimmune diseases, except for type 1 diabetes、hypothyroidism or skin conditions that do not require systemic treatment (vitiligo、psoriasis or alopecia)；
• 12.Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
• 13.Patients with Crohn's disease and ulcerative colitis;
• 15.Patients with known hypersensitivity to Nimotuzumab or its components;
• 17.Patients with neurological or psychiatric disorders affecting cognitive ability;
• 19.Any condition that, in the opinion of the Investigator, may be inappropriate for patients in the study.

Lab values

• 9.Had the following serious medical conditions: a) Uncontrolled hypertension (defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg), or had experienced a hypertensive crisis; b) Myocardial infarction and unstable angina occurred within 6 months before randomization; c) Decompensated heart failure within three months before enrollment (NYHA class III and IV); d) The presence of severe arrhythmias requiring long-term medical intervention, except in patients with asymptomatic atrial fibrillation with stable ventricular rate; e) Left ventricular ejection fraction (LVEF)\<50%; f) The presence of uncontrolled hyperglycemia; g) The presence of uncontrollable infections；

Other

• 3.Ureteral obstruction, inability to place ureteral stent or pyelostomy;
• 4.Pregnant or lactating women;
• 14.Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
• 16.Patients with contraindications to cisplatin、carboplatin and paclitaxel;

• 1.Aged 18-80 years old;
• 2.Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
• 3.At least one measurable lesion according to RECIST 1.1;
• 4.Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria: Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 1.5 × 10\^9/L and white blood cell count ≥ 3.0 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN ; Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
• 5.ECOG score 0-1 points;
• 6.Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation); Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
• 7.Compliance is good and informed consent is voluntarily signed.