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

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Dec 16, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for women with locally advanced cervical squamous cell carcinoma, a type of cervical cancer. The study aims to find out if a drug called nimotuzumab, when combined with standard chemoradiotherapy (a treatment that uses both chemotherapy and radiation), is more effective and safe compared to just chemoradiotherapy alone. This trial is not yet recruiting participants, but it will focus on women aged 18 to 75 years who have been diagnosed with this specific type of cancer and meet certain health criteria.

To be eligible for the trial, participants need to have a measurable tumor and good overall health, including certain blood test results. Women who can have children must have a negative pregnancy test and agree to use birth control during the trial. Participants can expect to receive close monitoring throughout the study and will be asked to provide their informed consent before joining. It’s important to note that individuals with specific health conditions or previous cancer treatments may not be able to participate. This trial represents an opportunity to explore a potentially promising treatment for cervical cancer.

Gender

FEMALE

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.