Actively Recruiting
Clinical Study of 177Lu-CTR-FAPI In the Treatment of Patients With Advanced, Metastatic Solid Tumors
Led by Yan Xing · Updated on 2025-11-17
4
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm, open-label clinical study of 177Lu-CTR-FAPI injection in the treatment of patients with advanced, metastatic solid tumors i.e. pancreatic cancer, to assess safety, radio-dosimetry, and efficacy per RESIST 1.1.
CONDITIONS
Official Title
Clinical Study of 177Lu-CTR-FAPI In the Treatment of Patients With Advanced, Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unresectable, advanced, or metastatic solid tumors confirmed by biopsy who have failed or lack standard treatments or refuse them
- Preferred tumor types include pancreatic cancer, breast cancer (various subtypes), and soft tissue sarcoma
- Patients with specific cancer types must have progressed after or be intolerant to required lines of therapy as specified
- Age 18 years or older, any sex
- Able to understand and sign informed consent and comply with study procedures
- ECOG performance status of 0 or 1
- Positive FAP expression in tumor lesions confirmed by FAPI PET/CT
- Agree to provide archived or fresh tumor tissue for evaluation if available
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Previous anti-tumor toxicities recovered to grade 0-1
- Adequate organ function meeting specified blood counts, liver, kidney, and ECG parameters
- Fertile subjects agree to effective contraception during treatment and for specified months after last dose
You will not qualify if you...
- Brain metastases, meningiomas, or other central nervous system lesions present at screening
- Severe allergy to contrast agents or claustrophobia
- Expected survival less than 6 months
- Blood transfusion received within 2 weeks before first dose
- Systemic antitumor therapies within 4 weeks before first dose
- Participation in other investigational drug/device trials within 4 weeks before first dose
- Major surgery within 4 weeks before first dose or planned major surgery during study
- Active infections requiring intravenous medication within 4 weeks before first dose
- Previous radionuclide therapy or external beam radiotherapy within 4 weeks before first dose
- History of other cancers within 5 years before first dose
- Severe cardiovascular or cerebrovascular diseases, or poorly controlled diabetes
- Pleural effusion or ascites requiring treatment or uncontrolled at screening
- Pregnant or breastfeeding females
- Poor compliance or inability to cooperate with treatment and follow-up at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yan Xing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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