NCT04976478尚未招募不适用
A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival(DFS)
研究概览
简要总结
To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma
详细描述
This is a perspective, multi-center, open-label and single arm study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age≥65 years old
- •Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
- •At least one measurable lesion according to RECIST 1.1 guideline
- •Patients are intolerant to or refuse chemotherapy.
- •No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:
- •Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L； Platelet count≥100×109/L； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；
- •Serum creatinine≤1.5×ULN or CrCl> 60 mL/min(according toCockcroft-Gault):
- •Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 / (72×Scr mg/dl)
- •ECOG score 0-2
- •Expectancy of life is at least 3 months.
- •Eligible for pelvic MRI examination.
- •The patients voluntarily received nimotuzumab combined with radiotherapy.
- •Patients can comply with the protocol and are willing to sign informed consent.
排除标准
- •Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
- •Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
- •Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.
- •.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.
- •Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.
- •Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.
- •Intracavitary brachytherapy cannot be performed that was assessed by the investigator.
- •Other factors were assessed by investigators to be unsuitable to this study.
研究组 & 干预措施
observation group
All patients will be treated with Nimotuzumab combined with radiotherapy.
干预措施: Nimotuzumab (Drug)
observation group
All patients will be treated with Nimotuzumab combined with radiotherapy.
干预措施: EBRT combined with brachytherapy (Radiation)
结局指标
主要结局
3-year disease-free survival(DFS)
时间窗: up to 3 years
The rate of patient without disease in 3 years after treatment
次要结局
- The change of tumor related markers(up to 3 years)
- The change of cervical tumor(At diagnosis and before brachytherapy)
- Complete response rate(CRR)(3 months later after treatment)
- 3-year overall survival(OS)(up to 3 years)
- SAFETY(up to 3 years)
- Objective response rate(ORR)(3 months later treatment)
- QUALITY OF LIFE(QoL)(up to 3 years)
研究者
Junjie Wang
Department director
Peking University Third Hospital
研究点 (1)
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