Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Treatments: Cisplatin; Nimotuzumab

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.