Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310590
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-26
Brief Title:
Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
Chengdu New Radiomedicine Technology Co LTD
Organization:
Chengdu New Radiomedicine Technology Co LTD
Study Overview
Official Title:
Study on the Safety and Effectiveness of NRT6003 Injection in Patients With Unresectable Hepatocellular Carcinoma HCC
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC
Detailed Description:
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable HCC remain unknown This trial is a prospective multicenter open-label single-arm phase I trial designed to evaluate the safety and efficacy of NRT6003 injection
The primary objective is to evaluate the safety of NRT6003 Injection While the secondary objectives include the assessments of the antitumoral efficacy the improvement of patients quality of life and the distribution characteristics of Yttrium-90 in body
The primary objective is to evaluate the safety of NRT6003 Injection While the secondary objectives include the assessments of the antitumoral efficacy the improvement of patients quality of life and the distribution characteristics of Yttrium-90 in body
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20230515 | OTHER | Center for Drug Evaluation NMPA | None |