177Lu-CTR-FAPI Radiotherapy for Thyroid Cancer

Trial details

Who runs it

SHAOYAN LIU

Trial code

NCT07438847

Record updated

27 February 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: 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; Active infection within 4 weeks before the first dose; 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; Presence of CTR-FAPI-negative lesions (i.e., malignant lesions on contrast-enhanced CT/MRI without uptake on 68Ga-CTR-FAPI PET/CT); Known allergy to contrast agents; History of symptomatic central nervous system metastases; Any other condition deemed inappropriate for participation by the investigator (e.g., poor compliance, inability to cooperate with treatment and follow-up); Insufficient major organ function; Severe or uncontrolled comorbidities; Presence of pleural effusion or ascites requiring intervention or judged uncontrolled by the investigator at screening; Women who are pregnant, breastfeeding, or planning pregnancy; Severe claustrophobia.

ClinicalTrials.gov NCT07438847