This trial is a prospective, observational Phase II clinical study. For patients with locally advanced and/or metastatic medullary thyroid carcinoma with RET gene mutations who require systemic treatment, they are randomly assigned to either the Pralsetinib or Anlotinib observation cohort based on their clinical treatment choices. The treatment continues until disease progression or the occurrence of intolerable adverse reactions. At the same time, the correlation between the efficacy and safety of the drugs and the RET gene mutation subtypes is analyzed, and the resistance mechanisms of Anlotinib and Pralsetinib are preliminarily explored to provide more evidence for the clinical treatment of patients with locally advanced or metastatic MTC in China.
Age ≥18 years.
Pathologically confirmed medullary thyroid carcinoma (MTC).
Patients with locally advanced or metastatic MTC who require systemic treatment.
Disease progression within 14 months before the screening visit.
Platelet count < 75 × 10^9/L.
Absolute neutrophil count (ANC) < 1.0 × 10^9/L.
Hemoglobin < 9.0 g/dL, with the possibility of elevating hemoglobin to 9.0 g/dL or higher through red blood cell transfusion and erythropoietin use, provided such treatment is completed at least 2 weeks before the first administration of the study drug.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) without liver metastases; > 5 × ULN with liver metastases.
Patients with RET gene mutation-related locally advanced or metastatic medullary thyroid carcinoma (MTC) who require systemic treatment.
Cohort
Prospective
Not listed
To evaluate the objective response rate (ORR) of Pralsetinib or Anlotinib in patients with RET gene mutation-related locally advanced or metastatic medullary thyroid carcinoma (MTC) who require systemic treatment
Defined as complete response (CR) or partial response (PR) according to RECIST v1.1
Progression-free survival (PFS) as assessed by Investigator
Duration of Response (DOR)
Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first
Disease control rate (DCR)
Changes in blood calcitonin (CT) and carcinoembryonic antigen (CEA)
To explore the correlation of different RET gene mutation subtypes and other tumor tissue biomarkers with the efficacy and safety of drug treatment
Preliminary exploration of resistance mechanisms in Chinese patients with locally advanced or metastatic RET-mutant medullary thyroid carcinoma (MTC) requiring systemic therapy after treatment with pralsetinib.
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