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

Kanghong Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Retinoblastoma

Treatments: Drug: Conbercept ophthalmic injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04990271

V2.3

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient's guardian signs an informed consent form and is willing to receive follow-up according to the schedule of the trial;

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

Subjects with any of the following eye conditions:

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Conbercept intravitreal Injection

Experimental group

Treatment:

Drug: Conbercept ophthalmic injection