nimotuzumab combined with chemoradiotherapy versus chemoradiotherapy for local advanced cervical squamous cell carcinoma

Conditions: Cervical Squamous Cell Carcinoma

Summary: to investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.

this study adopts a multi-center, randomized controlled, open-label clinical trial design.

Eligibility criteria:
inclusion criteria: 1. aged 18-75 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 ≥ 2 × 109/l or white blood cell count ≥ 4.0 × 109/l; platelet count ≥ 100 × 109/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 0-2 points; 6. expected survival ≥ 3 months; 7. 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); 8. no intrauterine device; 9. women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial; 10. 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, systemic chemotherapy, 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 vaginal bleeding or at risk of fistula; 6. human immunodeficiency virus (hiv) infection; 7. 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); 8. patients have a serious underlying condition that precludes safe administration of trial treatment. including but not limited to active infection requiring systemic drug therapy: decompensated heart failure (nyha class iii and iv), unstable angina pectoris, acute myocardial infarction within 3 months prior to enrollment; 9. patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma); 10. patients with crohn's disease and ulcerative colitis; 11. patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks; 12. patients with known hypersensitivity to nimotuzumab or its components; 13. patients with contraindications to cisplatin; 14. patients with neurological or psychiatric disorders affecting cognitive ability; 15. patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator; 16. other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.