Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progress free survival rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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)
排除标准
- •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.
研究组 & 干预措施
experimental group
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
干预措施: Nimotuzumab (Drug)
experimental group
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
干预措施: Cisplatin (Drug)
experimental group
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
干预措施: external-beam radiation (Radiation)
experimental group
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
干预措施: brachytherapy (Radiation)
control group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
干预措施: Cisplatin (Drug)
control group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
干预措施: external-beam radiation (Radiation)
control group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
干预措施: brachytherapy (Radiation)
结局指标
主要结局
progress free survival rate
时间窗: 3 years
The rate of patient without progress disease in 3 years after treatment
次要结局
- Overall survival rate(3 years)
- No distant metastatic survival.(3 years)
- Local area control rate.(3 years)
- objective response rate(3 years)