Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278454
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-19
Brief Title:
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer LAPC
Sponsor:
Chengdu New Radiomedicine Technology Co LTD
Organization:
Chengdu New Radiomedicine Technology Co LTD
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer LAPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This is a single arm open label multi-center phase I study including phase Ia dose escalation and phase Ib dose expansion Safety review committee SRC will be formed to monitor safety and efficacy data through the study And the independent review committee IRC will be formed to monitor efficacy data through the study
Detailed Description:
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC remain unknown This trial is a prospective multicenter open-label single-arm phase I trial designed to evaluate the safety and efficacy of NRT6008 injection The primary objective is to evaluate the safety of NRT6008 Injection While the secondary objectives include the assessments of the preliminary efficacy In addition the distribution of NRT6008 injection in human body and the changes of tumor biomarkers and the improvement of cancer pain status of participants after administration will also be evaluated
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 |
|---|---|---|---|
| CTR20240312 | OTHER | Center for Drug Evaluation NMPA | None |