Status:
COMPLETED
Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Refractory Solid Tumor
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand t...
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 P...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 and older.
- Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis).
- Progressive disease after multiple-lines treatment.
- Completion of entry into 68Ga-FAPI-46 study and completion of scan. The tumor lesions showing increased radiotracer uptake on 68Ga-FAPI-46 PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions).
- Able to remain motionless for up to 30-60 minutes per scan.
Exclusion
- Serum creatinine level \>150 μmol/L.
- Hemoglobin level \<8.0 g/dL; white-cell count \< 2.0×109/L; platelet count \< 50×109/L; total bilirubin level \>3 times the upper limit of the normal range and serum albumin level \<2.0 g/dL.
- Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- Participants with severe allergy, or hypersensitivity to radiographic contrast material.
- Participants with claustrophobia.
- Pregnant or lactating women.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05963386
Start Date
February 22 2022
End Date
October 5 2024
Last Update
March 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000