NCT04990271Unknown2 期
A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma
Chengdu Kanghong Biotech Co., Ltd.5 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年7月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma
研究概览
简要总结
This prospective, multi-center, open single-arm Phase II clinical trial is designed to investigate the efficacy and safety of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's guardian signs an informed consent form and is willing to receive follow-up according to the schedule of the trial;
- •Children of more than 3 months and under 5 years of age who have not received any anti-cancer treatment;
- •The target eye must meet the following requirements:
- •Clinically diagnosed as monocular retinoblastoma; According to the IIRC diagnostic criteria, the treatment eye is classified as Group E stage without clinical high-risk factors (Table 1); No refractive medium turbidity and/or pupillary abnormalities that affect the fundus examination; IOP≤21mmHg.
- •Sufficient organ function at baseline.
排除标准
- •Subjects with any of the following eye conditions:
- •Patients diagnosed as stage E retinoblastoma in one eye, but with high-risk factors: neovascular glaucoma; refractive interstitial opacity caused by anterior chamber, vitreous or subretinal hemorrhage; tumor invasion of optic nerve posterior to the cribriform plate and choroid (range of diameter> 2 mm), sclera, and anterior chamber;
- •Treatment-naïve pediatric patients;
- •Patients with any of the following systemic diseases:
- •With a history of allergies or have allergic reactions to fluorescein sodium, with a history of allergies to protein products for treatment or diagnosis, and have allergic reactions to two or more drugs and/or non-drug factors, or suffering from allergic diseases;
- •Low birth weight children, and severely growth-stunted children;
- •Children who need systemic treatment for other system diseases;
- •Any condition that should be excluded from the study in the opinion of the investigator.
研究组 & 干预措施
Conbercept intravitreal Injection
Experimental
干预措施: Conbercept ophthalmic injection (Drug)
结局指标
主要结局
To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma
时间窗: 1 year
12-month ocular salvage rate: calculate the number and percentage of subjects who reach 12-month ocular salvage rate, and use the exact probability method to estimate 95% CI.
次要结局
未报告次要终点
研究者
研究点 (5)
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