A Prospective Cohort Study of Pralsetinib or Anlotinib in the Treatment of Locally Advanced and/o… (NCT07048964) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Cohort Study of Pralsetinib or Anlotinib in the Treatment of Locally Advanced and/or Metastatic Medullary Thyroid Carcinoma With RET Gene Mutations
40 participantsStarted 2025-08-01
Plain-language summary
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.
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.
. 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.
. Total bilirubin \> 1.5 × ULN, \> 3 × ULN with liver metastases; in the case of Gilbert's syndrome, total bilirubin \> 3 × ULN and direct bilirubin \> 1.5 × ULN.
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.
What they're measuring
1
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
Timeframe: 24 months
Trial details
NCT IDNCT07048964
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences