NCT07438847 177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
| NCT ID | NCT07438847 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | SHAOYAN LIU |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of thyroid cancer according to the 2022 WHO classification of thyroid tumors. Differentiated thyroid carcinoma must be diagnosed as radioactive iodine-refractory (RAIR) by a nuclear medicine specialist. * Evidence of progressive disease based on RECIST 1.1 criteria in pre-treatment imaging. * Prior surgical resection of resectable cervical lesions, with currently unresectable systemic disease. * Previous targeted therapy was discontinued due to intolerance, or lack of benefit from targeted therapy assessed by investigator, or patient refusal. * At least one measurable target metastatic lesion on contrast-enhanced CT/MRI (longest diameter of lesion ≥ 10 mm or shortest diameter of lymph node ≥ 15 mm). * Positive CTR-FAPI uptake in lesions, defined as SUVmax \> 10 in more than half of the lesions on 68Ga-CTR-FAPI PET/CT. * Life expectancy \> 6 months. * ECOG performance status ≤ 2. * Prior anti-tumor therapy-related toxicities that recoverd to Grade 0 or 1 (except alopecia, pigmentation, or chronic radiation toxicities and deemed irreversible by the investigator). * For subjects with fertility: agreement to use effective contraception during treatment and 4 months (males) or 7 months (females) after the last dose. * Voluntary participation and signed informed consent. Exclusion Criteria: * Presence of CTR-FAPI-negative lesions (i.e., malignant lesions on contrast-enhanced CT/MRI without uptake on 68Ga-CTR-FAPI PET/CT). * Prior therapeutic radionuclide therapy (except 131I). * Systemic anti-cancer therapy (including chemotherapy, targeted therapy, immunotherapy, radionuclide therapy, or anti-tumor traditional Chinese medicine) within 4 weeks before the first dose. * Participation in another drug or device clinical trial within 4 weeks before the first dose. * Insufficient major organ function. * Severe or uncontrolled comorbidities. * Presence of pleural effusion or ascites requiring intervention or judged uncontrolled by the investigator at screening. * Active infection within 4 weeks before the first dose. * Women who are pregnant, breastfeeding, or planning pregnancy. * Known allergy to contrast agents. * History of symptomatic central nervous system metastases. * Other concurrent malignancies. * Surgery under general anesthesia within 8 weeks before the first dose. * History of acute coronary syndrome or stroke within 8 weeks before the first dose. * Severe claustrophobia. * Any other condition deemed inappropriate for participation by the investigator (e.g., poor compliance, inability to cooperate with treatment and follow-up).
Contact & Investigator
Yansong Lin, M.D.
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT07438847 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07438847 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07438847 currently recruiting?
Yes, NCT07438847 is actively recruiting participants. Contact the research team at zrkong@126.com for enrollment information.
Where is the NCT07438847 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07438847 clinical trial?
NCT07438847 is sponsored by SHAOYAN LIU. The principal investigator is Yansong Lin, M.D. at Peking Union Medical College Hospital. The trial plans to enroll 12 participants.
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