Thyroid cancer
Conditions
Interventions
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old; 2.According to the 2022 WHO Thyroid Tumor Classification Criteria, patients must have a clear pathological diagnosis of thyroid cancer from participating center pathology examination, including DTC, MTC, ATC, etc. Among them, DTC patients need to be assessed and diagnosed as RAIR-DTC by nuclear medicine physicians; 3.Presence of progressive systemic tumor burden, defined as disease progression (PD) according to RECIST 1.1 criteria based on pre-treatment imaging examination; 4.Have undergone previous surgical treatment to remove resectable neck lesions, and current in-body lesions cannot be removed by surgery; 5.Have received previous targeted therapy but cannot tolerate severe adverse reactions, or physicians assess that targeted therapy is not beneficial, or patients refuse targeted therapy; 6.At least one measurable target lesion available for post-treatment assessment in enhanced CT/MRI results, defined as lesion longest diameter >= 10mm or metastatic lymph node shortest diameter >= 15mm; 7.Positive CTR-FAPI uptake in lesions, defined as more than half of the lesions with SUVmax > 10 in 68Ga-CTR-FAPI PET/CT; 8.Low CTR-FAPI uptake in potential dose-limiting organs (including liver, bone marrow, pancreas), defined as SUVmax < 5 or SUVmean < 3 in these dose-limiting organs; 9.Expected survival greater than 6 months; 10.ECOG score <= 2; 11.Previous anti-tumor treatment toxicity recovered to grade 0 or 1 (except for hair loss, pigmentation, long-term radiotherapy toxicity, and toxicity judged by the investigator as unrecoverable); 12.Fertile subjects voluntarily use effective contraception during treatment and within 4 months (for males) or 7 months (for females) after the last use of study medication; 13.Voluntary participation in this trial.
Exclusion criteria
Exclusion criteria: 1.Presence of lesions with negative CTR-FAPI uptake, defined as lesions considered malignant on contrast-enhanced CT/MRI but showing no uptake on 68Ga-CTR-FAPI PET/CT; 2.Prior receipt of therapeutic doses of radionuclide therapy other than 131I; 3.Received systemic therapy (including chemotherapy, targeted therapy, immunotherapy, radionuclide therapy, anti-tumor Chinese medicine, etc.) within 4 weeks before the first administration; 4.Participated in drug or device clinical research within 4 weeks before the first administration; 5.Major organ dysfunction, with specific criteria as follows: a) Renal insufficiency (Cr clearance rate 3×ULN or ALB 3×ULN); 6.Presence of severe or uncontrolled underlying diseases, including but not limited to: a) NYHA class II or above congestive heart failure, or severe arrhythmias requiring medication; b) Severe cardiovascular/cerebrovascular/valvular diseases; c) Poorly controlled diabetes; 7.Presence of pleural effusion or ascites requiring treatment, or judged by the investigator as uncontrollable at screening; 8.Active infection within 4 weeks before the first administration; 9.Women of childbearing potential, pregnant, or breastfeeding; 10.Known allergy to contrast agents; 11.History of neurological metastases with related symptoms; 12.Presence of other malignant tumors; 13.Received general anesthesia surgery within 8 weeks before the first administration; 14.History of ACS or cerebral infarction within 8 weeks before the first administration; 15.Severe claustrophobia; 16.Other situations considered unsuitable for clinical research by the investigator, such as poor compliance, inability to cooperate with treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event(AE), Serious Adverse Event(SAE);Dose Limiting Toxicity (DLT);Maximum Tolerated Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical Response Rate and Duration;Radiation dosimetry;RECIST Response Rate and Duration;Progression-Free Survival (PFS);Improvement in patients' quality of life;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactYansong Lin
Peking Union Medical College Hospital
Outcome results
None listed