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New treatment option for Thyroid Cancer
Official title 177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
ClinicalTrials.gov ID: NCT07438847
What this study is testing
What is 177Lu-CTR-FAPI therapy?
177Lu-CTR-FAPI therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of thyroid cancer according to the 2022 WHO classification of thyroid tumors. Differentiated thyroid carcinoma...
- 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 ≥...
You likely can't join if
- 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...
- Participation in another drug or device clinical trial within 4 weeks before the first dose.
- Insufficient major organ function.
- Severe or uncontrolled comorbidities.
See the full eligibility 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...
- 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 people 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.