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

NCT04990271 | Unknown Phase 2

• 1 other identifier: V2.3
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

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.

Conditions

Retinoblastoma

Keywords

Retinoblastoma; Conbercept; VEC Intravenous Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Conbercept intravitreal Injection

EXPERIMENTAL

Drug: Conbercept ophthalmic injection

Interventions

Conbercept ophthalmic injection DRUG

Monthly injection of Conbercept from 0\~5 months

Also known as: KH902

Conbercept intravitreal Injection

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patient's guardian signs an informed consent form and is willing to receive follow-up according to the schedule of the trial;
• Children of more than 3 months and under 5 years of age who have not received any anti-cancer treatment;
• 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.
• Sufficient organ function at baseline.

You may not qualify if:

• Subjects with any of the following eye conditions:
• 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;
• Treatment-naïve pediatric patients;
• Patients with any of the following systemic diseases:
• 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;
• Low birth weight children, and severely growth-stunted children;
• Children who need systemic treatment for other system diseases;
• Any condition that should be excluded from the study in the opinion of the investigator.

Sponsors & Collaborators

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

Study Sites (5)

Beijing Children's Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Henan Children's Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

The Second Xiangya Hospital Of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Central Study Contacts

Xianqun Fan

CONTACT

13901696788; fanxq@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 4, 2021
• Study Start: July 5, 2021
• Primary Completion: April 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)