Retinoblastoma
Conditions
Keywords
Retinoblastoma, Conbercept, VEC Intravenous Chemotherapy
Brief 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.
Interventions
Monthly injection of Conbercept from 0\ 5 months
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Chengdu Kanghong Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma | 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. |
Countries
China
Contacts
Primary ContactXianqun Fan
Outcome results
None listed