Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424301
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma
Sponsor:
Eye ENT Hospital of Fudan University
Organization:
Eye ENT Hospital of Fudan University
Study Overview
Official Title:
Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma A Two-center Prospective Single Arm Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retinoblastoma RB is the most common intraocular malignancy in children and accounts for 11 of all cancers in children under the age of 1 year Although the incidence of RB is low approximately 115000 120000 it tends to metastasize to the intracranial area through the optic nerve pathway leading to poor prognosis for patients with RB Currently with the emergence of new administration routes such as intravitreal and intrarterial chemotherapy the rate of eye preservation has been effectively improved However the use of high doses of chemotherapeutic agents may lead to visual impairments due to long-term retinal toxicity and some tumors recur or become resistant to chemotherapeutic agents after treatment In such cases ocular resection is the only option to prevent extraocular metastasis and death
Therefore studies on retinoblastoma are currently focused on finding new targeted therapies to increase anti-tumor activity and reduce side effects In this study a novel targeting NUDT21 siRNA drug will be used to treat patients with refractory retinoblastoma This drug promotes tumor apoptosis by regulating the 3UTR plus tail of SMC1A which makes the proliferative activity of tumor cells weaken and achieves tumor control At the same time since the targeted drug only focuses on tumor cells it has reduced side effects compared with existing local chemotherapy regimens
Based on the above background this study will explore the feasibility and effectiveness of intravitreal injection of NUDT21 siRNA in patients with refractory retinoblastoma through a two-center prospective study
Therefore studies on retinoblastoma are currently focused on finding new targeted therapies to increase anti-tumor activity and reduce side effects In this study a novel targeting NUDT21 siRNA drug will be used to treat patients with refractory retinoblastoma This drug promotes tumor apoptosis by regulating the 3UTR plus tail of SMC1A which makes the proliferative activity of tumor cells weaken and achieves tumor control At the same time since the targeted drug only focuses on tumor cells it has reduced side effects compared with existing local chemotherapy regimens
Based on the above background this study will explore the feasibility and effectiveness of intravitreal injection of NUDT21 siRNA in patients with refractory retinoblastoma through a two-center prospective study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None