177Lu-CTR-FAPI for thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label, single-arm phase I trial using a 3+3 dose-escalation design to characterize safety and dose-limiting toxicities of 177Lu-CTR-FAPI. Up to 12 eligible participants will receive intravenous 177Lu-CTR-FAPI starting at 100 mCi with 50 mCi dose increments, given every 6 weeks for up to four cycles while monitoring adverse events and dosimetry. Primary endpoint is safety and determination of the maximum tolerated dose; secondary endpoints include biochemical and radiological response and quality-of-life measures. Eligibility requires progressive, measurable thyroid cancer with high CTR-FAPI uptake on 68Ga-CTR-FAPI PET/CT and adequate performance status.

Why it matters

Who can join: the full rules

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).

Where it's running

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting
• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Yansong Lin, M.D. — Peking Union Medical College Hospital
• Study coordinator: Ziren Kong, M.D.
• Email: zrkong@126.com
• Phone: 0086-18500487274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.