Brief Title
A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma
Official Title
A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma
Condition
Retinoblastoma
Intervention
Conbercept ophthalmic injection
Study Arms / Comparison Groups
Conbercept intravitreal Injection
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
92
Start Date
July 5, 2021
Completion Date
July 15, 2023
Primary Completion Date
April 15, 2023
Eligibility 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.
Gender
All
Ages
3 Months - 5 Years
Accepts Healthy Volunteers
No
Contacts
, 13901696788, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04990271
Organization ID
V2.3
Responsible Party
Sponsor
Study Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Sponsor
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Verification Date
July 2021