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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);