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

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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

, , 


Verification Date

July 2021