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

Retinoblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990271
• Other study ID #: V2.3
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2021
• Est. completion date: July 15, 2023

Study information

• Verified date: July 2021
• Source: Chengdu Kanghong Biotech Co., Ltd.
• Contact: Xianqun Fan
• Phone: 13901696788
• Email: fanxq[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: July 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• Conbercept ophthalmic injection
Monthly injection of Conbercept from 0~5 months

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing
China	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

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma	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.	1 year