A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma
Primary Purpose
Retinoblastoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Conbercept ophthalmic injection
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring Retinoblastoma, Conbercept, VEC Intravenous Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Beijing Children's Hospital
- Henan Children's Hospital
- Renmin Hospital of Wuhan University
- The Second Xiangya Hospital Of Central South University
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Conbercept intravitreal Injection
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04990271
First Posted
July 23, 2021
Last Updated
July 27, 2021
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT04990271
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
Retinoblastoma, Conbercept, VEC Intravenous Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conbercept intravitreal Injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Conbercept ophthalmic injection
Other Intervention Name(s)
KH902
Intervention Description
Monthly injection of Conbercept from 0~5 months
Primary Outcome Measure Information:
Title
To evaluate the 1-year ocular salvage rate of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianqun Fan
Phone
13901696788
Email
fanxq@sjtu.edu.cn
Facility Information:
Facility Name
Beijing Children's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junyang Zhao
Phone
18601196456
Email
zhaojunyang@163.com
First Name & Middle Initial & Last Name & Degree
Mei Jin
Facility Name
Henan Children's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiantao Sun
Phone
18239966755
Email
sunxt38019896@163.com
First Name & Middle Initial & Last Name & Degree
Yuebing Lu
First Name & Middle Initial & Last Name & Degree
Shuang Sun
First Name & Middle Initial & Last Name & Degree
Lihui Xu
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wu
Phone
13971110611
Email
154957611@qq.com
First Name & Middle Initial & Last Name & Degree
Yunyun Zhou
Facility Name
The Second Xiangya Hospital Of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Tan
Phone
13875860564
Email
jasmintj@126.com
First Name & Middle Initial & Last Name & Degree
Sha Wang
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianqun Fan
Phone
139 0169 6788
Email
fanxq@sjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Renbing Jia
First Name & Middle Initial & Last Name & Degree
Jiayan Fan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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