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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- 3-year progression-free survival (PFS)
研究概览
简要总结
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.
详细描述
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
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
- •Aged 18-75 years old;
- •Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
- •At least one measurable lesion according to RECIST 1.1;
- •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;
- •ECOG score 0-2 points;
- •Expected survival ≥ 3 months;
- •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);
- •No intrauterine device;
- •Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
- •Compliance is good and informed consent is voluntarily signed.
排除标准
- •Cervical adenocarcinoma and rare pathological types of malignant tumors;
- •Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
- •Ureteral obstruction, inability to place ureteral stent or pyelostomy;
- •Pregnant or lactating women;
- •Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
- •Human immunodeficiency virus (HIV) infection;
- •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);
- •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;
- •Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
- •Patients with Crohn's disease and ulcerative colitis;
- •Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
- •Patients with known hypersensitivity to Nimotuzumab or its components;
- •Patients with contraindications to cisplatin;
- •Patients with neurological or psychiatric disorders affecting cognitive ability;
- •Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;
- •Other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.
研究组 & 干预措施
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
干预措施: Nimotuzumab (Drug)
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
干预措施: Cisplatin (Drug)
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
干预措施: External-beam radiation (Radiation)
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
干预措施: Brachytherapy (Radiation)
Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
干预措施: Cisplatin (Drug)
Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
干预措施: External-beam radiation (Radiation)
Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
干预措施: Brachytherapy (Radiation)
结局指标
主要结局
3-year progression-free survival (PFS)
时间窗: up to 3 years
The rate of patient without progress disease in 3 years after treatment
次要结局
- 3-year overall survival (OS)(up to 3 years)
- Complete response rate (CRR)(3 months later after treatment)
- Objective response rate (ORR)(3 months later after treatment)
- Incidence and severity of acute adverse events(up to 3 months complete treatment)
研究者
Junjie Wang
Principal Investigator
Peking University Third Hospital