A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma
NCT ID: NCT04990271
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
92 participants
INTERVENTIONAL
2021-07-05
2023-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Conbercept intravitreal Injection
Conbercept ophthalmic injection
Monthly injection of Conbercept from 0\~5 months
Interventions
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Conbercept ophthalmic injection
Monthly injection of Conbercept from 0\~5 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Children of more than 3 months and under 5 years of age who have not received any anti-cancer treatment;
3. 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.
4. Sufficient organ function at baseline.
Exclusion Criteria
1. 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;
2. Treatment-naïve pediatric patients;
Patients with any of the following systemic diseases:
1. 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;
2. Low birth weight children, and severely growth-stunted children;
3. Children who need systemic treatment for other system diseases;
4. Any condition that should be excluded from the study in the opinion of the investigator.
3 Months
5 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Chengdu Kanghong Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Children's Hospital
Beijing, Beijing Municipality, China
Henan Children's Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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V2.3
Identifier Type: -
Identifier Source: org_study_id
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