Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.

Inclusion Criteria:

• All volunteers will sign the informed consent.
• Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
• The FIGO stage (IIB-IVA) and was not available for surgical treatment.
• There is at least one tumor lesion that is measurable by RECIST.
• During the study, contraception should be ensured.
• Karnofsky performance status >60.
• WBC >= 3,000/mm^3
• Absolute granulocyte count >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• INR < 1.5
• Total bilirubin =< 1.5 mg/dL
• Serum creatinine =< 1.5 mg/dL
• AST and ALT =< 2.5 times upper limit of normal (ULN)
• Serum calcium =< 1.3 times ULN
• Hemoglobin >= 9g/dL (transfusion allowed)

Exclusion Criteria:

• Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
• Prior invasive malignancy (except nonmelanomatous skin cancer)
• Contraindication of chemotherapy;
• Rare pathological subtype;
• Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.