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

Phase 2

• Conditions: Retinoblastoma
• Interventions: Drug: Conbercept ophthalmic injection

• Registration Number: NCT04990271
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-05
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2023-04-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conbercept intravitreal Injection	Conbercept ophthalmic injection	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

The Second Xiangya Hospital Of Central South University; 🇨🇳 Changsha, Hunan, China

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Henan Children's Hospital; 🇨🇳 Zhengzhou, Henan, China

Beijing Children's Hospital; 🇨🇳 Beijing, Beijing, China