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

• Status: Recruiting
• Trial end date: 2023-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.
• Collaborator: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Criteria

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.