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

Inclusion Criteria:

• 1.Aged 18-80 years old;
• 2.Histologically diagnosed primary cervical squamous cell carcinoma, with clinicalstage 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, kidneydysfunction and immunodeficiency, laboratory test results meet the following criteria:Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 1.5 × 10^9/L and white blood cellcount ≥ 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 72hours prior to enrollment (postmenopausal women must have been amenorrheic for atleast 12 months to be considered of non-childbearing potential. A pregnancy test isnot required for women who have demonstrated tubal ligation); Women of childbearingpotential who are willing to take medically recognized contraceptive measures duringthe trial;
• 7.Compliance is good and informed consent is voluntarily signed.

Exclusion Criteria:

• 1.Cervical adenocarcinoma and rare pathological types of malignant tumors;
• 2.Previous surgery for cervical cancer, pelvic radiation therapy, systemicchemotherapy, tumor targeted therapy, immunotherapy;
• 3.Ureteral obstruction, inability to place ureteral stent or pyelostomy;
• 4.Pregnant or lactating women;
• 5.Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginalbleeding or at risk of fistula;
• 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 treatmentor planned to vaccinate during the study;
• 8.Human immunodeficiency virus (HIV) infection;Active hepatitis B (the quantitativedetection 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);
• 9.Had the following serious medical conditions: a) Uncontrolled hypertension (definedas systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg), or hadexperienced a hypertensive crisis; b) Myocardial infarction and unstable anginaoccurred within 6 months before randomization; c) Decompensated heart failure withinthree months before enrollment (NYHA class III and IV); d) The presence of severearrhythmias requiring long-term medical intervention, except in patients withasymptomatic atrial fibrillation with stable ventricular rate; e) Left ventricularejection fraction (LVEF)<50%; f) The presence of uncontrolled hyperglycemia; g) Thepresence of uncontrollable infections；
• 10.The presence of active or suspected autoimmune diseases, except for type 1diabetes、hypothyroidism or skin conditions that do not require systemic treatment (vitiligo、psoriasis or alopecia)；
• 11.Conditions requiring systemic treatment with corticosteroids or otherimmunosuppressive agents within 14 days before randomization；
• 12.Patients with a history of other malignant tumors (except cured cutaneous basalcell carcinoma);
• 13.Patients with Crohn's disease and ulcerative colitis;
• 14.Patients who are participating in other clinical trials or have stopped clinicaltrials for less than 4 weeks;
• 15.Patients with known hypersensitivity to Nimotuzumab or its components;
• 16.Patients with contraindications to cisplatin、carboplatin and paclitaxel;
• 17.Patients with neurological or psychiatric disorders affecting cognitive ability;
• 18.Patients whose lesions cannot be treated with intracavitary radiotherapy asassessed by the investigator;
• 19.Any condition that, in the opinion of the Investigator, may be inappropriate forpatients in the study.