A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma

Conditions
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Retinoblastoma

Intervention / Treatment
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* Drug: Conbercept ophthalmic injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conbercept intravitreal Injection<br> | Drug: Conbercept ophthalmic injection<br>* Monthly injection of Conbercept from 0 5 months<br>* Other names: KH902;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinoblastoma, Conbercept, VEC Intravenous Chemotherapy