Actively Recruiting
177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
Led by SHAOYAN LIU · Updated on 2026-02-27
12
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
SHAOYAN LIU
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, open-label, single-arm, dose-escalation phase I study, aiming to evaluate the safety and efficacy of 177Lu-CTR-FAPI (covalent targeted radioligand-fibroblast activation protein inhibitor), a novel radiopharmaceutical in the treatment of thyroid cancer. The primary endpoint of the study is the safety of 177Lu-CTR-FAPI, and the secondary endpoints include treatment response and dosimetry evaluation.
CONDITIONS
Official Title
177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed thyroid cancer according to 2022 WHO classification
- Differentiated thyroid carcinoma diagnosed as radioactive iodine-refractory by a nuclear medicine specialist
- Evidence of progressive disease based on RECIST 1.1 in pre-treatment imaging
- Prior surgical removal of resectable cervical lesions, with current unresectable systemic disease
- Previous targeted therapy discontinued due to intolerance, lack of benefit, or patient refusal
- At least one measurable metastatic lesion on contrast-enhanced CT or MRI (lesion diameter 10 mm or lymph node diameter 15 mm)
- Positive CTR-FAPI uptake in lesions (SUVmax > 10 in more than half of lesions on 68Ga-CTR-FAPI PET/CT)
- Life expectancy greater than 6 months
- ECOG performance status 2 or lower
- Prior anti-tumor therapy toxicities recovered to Grade 0 or 1 (except irreversible alopecia, pigmentation, or chronic radiation toxicities)
- Agreement to use effective contraception during treatment and for 4 months (males) or 7 months (females) after last dose
- Voluntary participation with signed informed consent
You will not qualify if you...
- Presence of CTR-FAPI-negative malignant lesions without uptake on 68Ga-CTR-FAPI PET/CT
- Prior therapeutic radionuclide therapy except 131I
- Systemic anti-cancer therapy within 4 weeks before first dose
- Participation in another drug or device clinical trial within 4 weeks before first dose
- Insufficient major organ function
- Severe or uncontrolled other medical conditions
- Pleural effusion or ascites requiring intervention or uncontrolled at screening
- Active infection within 4 weeks before first dose
- Women who are pregnant, breastfeeding, or planning pregnancy
- Known allergy to contrast agents
- History of symptomatic central nervous system metastases
- Other concurrent cancers
- Surgery under general anesthesia within 8 weeks before first dose
- History of acute coronary syndrome or stroke within 8 weeks before first dose
- Severe claustrophobia
- Any condition making participation inappropriate as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
Z
Ziren Kong, M.D.
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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