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| Name | Class |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conbercept intravitreal Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept ophthalmic injection | Drug | Monthly injection of Conbercept from 0~5 months |
|
| 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 | 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 |
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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 with any of the following systemic diseases:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianqun Fan | Contact | 13901696788 | fanxq@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Henan Children's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | China |
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| The Second Xiangya Hospital Of Central South University | Not yet recruiting | Changsha | Hunan | China |
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| Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D012175 | Retinoblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
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