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

Last updated: July 27, 2021
Sponsor: Chengdu Kanghong Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Retinoblastoma

Treatment

N/A

Clinical Study ID

NCT04990271
V2.3
  • Ages 3-5
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient's guardian signs an informed consent form and is willing to receivefollow-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 anyanti-cancer treatment;
  3. The target eye must meet the following requirements: Clinically diagnosed as monocular retinoblastoma; According to the IIRC diagnosticcriteria, the treatment eye is classified as Group E stage without clinical high-riskfactors (Table 1); No refractive medium turbidity and/or pupillary abnormalities thataffect the fundus examination; IOP≤21mmHg.
  4. Sufficient organ function at baseline.

Exclusion

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 thecribriform 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:
  3. With a history of allergies or have allergic reactions to fluorescein sodium, with ahistory of allergies to protein products for treatment or diagnosis, and have allergicreactions to two or more drugs and/or non-drug factors, or suffering from allergicdiseases;
  4. Low birth weight children, and severely growth-stunted children;
  5. Children who need systemic treatment for other system diseases;
  6. Any condition that should be excluded from the study in the opinion of theinvestigator.

Study Design

Total Participants: 92
Study Start date:
July 05, 2021
Estimated Completion Date:
July 15, 2023

Connect with a study center

  • Beijing Children's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Henan Children's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • The Second Xiangya Hospital Of Central South University

    Changsha, Hunan
    China

    Site Not Available

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

    Shanghai, Shanghai
    China

    Active - Recruiting

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