NCT03476018已完成3 期
Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer
Zeria Pharmaceutical2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年4月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in the number of immunological cells
研究概览
简要总结
The objective of this clinical trial is to evaluate the change of the immunological parameter levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage (2008): IIIB, cervical cancer
- •Pathologically confirmed squamous cell carcinoma of the cervix
- •Subjects with treatment-naive cervical cancer
- •Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node
- •Subjects ≥21, ≤79 years of age at informed consent
- •Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy
- •Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy
- •Eastern Cooperative Oncology Group Performance Status: 0-2
- •Subjects with the following organ functions; (1) WBC ≥3,000/mm3 (2) Platelet count ≥100,000/mm3 (3) Hemoglobin ≥9.5 g/dL (correction by medication, e.g. blood transfusion, iron compounds, is allowed) (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (6) Creatinine clearance: ≥50 mL/min
- •Subjects who are willing to give informed consent
排除标准
- •Subjects who have a double cancer or are being treated for that
- •Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent
- •Subjects with cancer of the cervical stump which is judged by the investigator
- •Subjects who have a history of being diagnosed of autoimmune disease
- •Subjects who have a history of radiotherapy in the pelvis
- •Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum
- •Subjects complicated with a serious drug allergy
- •Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)
- •Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period
- •Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)
- •Subjects with symptomatic tuberculosis at the date of obtaining consent
- •Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent
- •Other subjects considered inappropriate to participate in the trial by the investigator
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebos (Drug)
0.2 microgram Z-100
Experimental
干预措施: Z-100 (Drug)
2 microgram Z-100
Experimental
干预措施: Z-100 (Drug)
20 microgram Z-100
Experimental
干预措施: Z-100 (Drug)
结局指标
主要结局
Change in the number of immunological cells
时间窗: 2 years
次要结局
- Disease-specific survival(2 years)
- Recurrence-free survival(3 years)
- Rate of adverse events/adverse drug reactions(2 years)
- Overall survival(3 years)
研究者
研究点 (2)
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