Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2025-12-17 @ 1:20 AM
Study NCT ID:
NCT05963386
Status:
None
Last Update Posted:
2025-03-28 00:00:00
First Post:
2023-07-17 00:00:00
Brief Title:
Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
An Open-Label, Non-Randomized, Single-Center, Investigator-initiated Phase II Trial to Determine the Efficacy and Safety of 177Lu-DOTA-EB-FAPI in Patients With Various End-stage Solid Tumors
Status:
None
Status Verified Date:
2025-03
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 investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.
Detailed Description:
This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PETCT The fixed dose of 177Lu-DOTA-EB-FAPI is 33GBq 90 mCi per cycle Treatment is planned for up to 4 cycles and the time interval between cycles is 6 weeks The primary endpoint assessed the radiological response according to RECIST criteria after completion of radioligand therapy The secondary endpoints included progression-free survival PFS overall survival OS dosimetry and safety of 177Lu-DOTA-EB-FAPI
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