Anaplastic Thyroid Cancer Clinical Trials

∙ Participants must meet all of the following criteria:

∙ 1\. Age ≥ 18 years at the time of informed consent. 2. Histologically confirmed unresectable, locally advanced, or metastatic:

• Anaplastic thyroid carcinoma (ATC), or

• Poorly differentiated thyroid carcinoma (PDTC), or

• Radioactive iodine-refractory differentiated thyroid carcinoma (RAIR-DTC), including papillary thyroid carcinoma or follicular thyroid carcinoma and variants.

• 3\. For ATC or PDTC:

• No BRAF V600E mutation, RET fusion, NTRK fusion, or ALK fusion;

• Or harboring such alterations but have failed prior standard first-line targeted therapy.

• 4\. For RAIR-DTC: Disease must be refractory to radioactive iodine (RAI), defined as at least one of the following:

• No RAI uptake in measurable lesions;

• Radiographic progression within 12 months after RAI therapy;

• Cumulative RAI dose \>600 mCi (or iodine-equivalent);

• Fluorodeoxyglucose (FDG)-avid measurable disease;

• Failure of prior multi-target tyrosine kinase inhibitor (TKI) therapy. 5. At least one measurable lesion per RECIST version 1.1. 6. ECOG performance status 0-2. 7. Life expectancy ≥ 12 weeks. 8. Adequate hematologic function:

• Absolute neutrophil count ≥ 1.2 × 10⁹/L

• Platelet count ≥ 100 × 10⁹/L

• Hemoglobin ≥ 90 g/L 9. Adequate hepatic function:

• AST and ALT ≤ 2.5 × upper limit of normal (ULN)

• ≤ 5 × ULN if liver metastases present

• Total bilirubin ≤ 1.5 × ULN 10. Adequate renal function:

• Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)

‣ No active autoimmune disease requiring systemic therapy.

⁃ No concurrent active malignancy requiring treatment.

⁃ Willing and able to provide written informed consent.