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

July 27, 2021 updated by: Chengdu Kanghong Biotech Co., Ltd.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Children's Hospital
        • Contact:
        • Sub-Investigator:
          • Mei Jin
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Children's Hospital
        • Contact:
        • Sub-Investigator:
          • Yuebing Lu
        • Sub-Investigator:
          • Shuang Sun
        • Sub-Investigator:
          • Lihui Xu
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
        • Sub-Investigator:
          • Yunyun Zhou
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • The Second Xiangya Hospital Of Central South University
        • Contact:
        • Sub-Investigator:
          • Sha Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Renbing Jia
        • Sub-Investigator:
          • Jiayan Fan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conbercept intravitreal Injection
Drug: Conbercept ophthalmic injection
Monthly injection of Conbercept from 0~5 months
Other Names:
  • KH902

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Collaborators

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Anticipated)

April 15, 2023

Study Completion (Anticipated)

July 15, 2023

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V2.3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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