Study of Anlotinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer (NCT06062563) | Clinical Trial Compass
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Study of Anlotinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer
China10 participantsStarted 2023-11-11
Plain-language summary
This study aims to observe and explore the efficacy and safety of Anlotinib combined with penpulimab in the treatment of radioiodine refractory differentiated thyroid cancer with first-line resistance to angiogenesis inhibitors, and to summarize the treatment experience of population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients voluntarily joined the study, signed the informed consent;
✓. Patients were pathologically confirmed as locally advanced or metastatic differentiated thyroid cancer (DTC), having at least one measurable lesion (Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
✓. Patients≥18 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 6 months;
✓. Possessing imaging or clinical evidence of disease progression within the first 18 months of enrollment;
✓. Progression of at least one anti-vascular drug（no more than 2）；
✓. Tg and structural imaging examinations were performed at least twice before enrollment；
✓. Meet any of the following while meeting the above 3 items:（1）Lesions were not iodine-avid；（2） The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months. （3） Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
✓. Major organ functions meet the following criteria within 7 days prior to the treatment:
Exclusion criteria
✕. Complicated diseases and history:
✕. Histologic subtypes of thyroid cancer other than the differentiated type (e.g., medullary carcinoma, lymphoma, or sarcoma) could not be enrolled; Patients currently have or had other malignancies within 5years. Cured localized tumors could be enrolled（e.g., Skin basal cell carcinoma）
✕. Subjects with any severe and/or uncontrolled heart disease, including:
✕. According to the criteria of New York Heart Association (NYHA) grade II or above cardiac insufficiency or echocardiography: LVEF (left ventricular ejection fraction) \<50%;
✕. Unstable angina
✕. A myocardial infarction had occurred within 1 year before the beginning of the treatment
✕. Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention
✕. QTc ≥450ms (male), QTc ≥470ms (female) (classified by New York heart association, NYHA);