177Lu-CTR-FAPI for the Treatment of Thyroid Cancer: A Prospective, Multi-center, Open-labeled, Single-arm, Phase I Study
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.
• 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.