Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT04612894
Eligibility Criteria:
Inclusion Criteria:
* The patient volunteered to participate in the study and signed an informed consent form;
* Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis;
* Preoperative assessment of locally advanced thyroid cancer (unable to achieve R0/1 resection or T4 disease);
* Have at least one measurable lesion (RECIST 1.1);
* Age\>=14 years, Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Patient agree to receive surgery/ core needle biopsy before and after neoadjuvant treatment.
* The main organ functions meet the criteria before treatment.
Exclusion Criteria:
* Patients who have previously been treated with immune checkpoint inhibitors (including but not limited to nivolizumab, pembrolizumab, teriplizumab, sintilizumab, etc.);
* Received external radiation therapy or iodine-131 therapy within the past 28 days; or planned systemic anti-tumor therapy during this study;
* Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.);
* With other uncontrolled / under treatment malignancies;
* Those who have multiple factors (such as inability to swallow) that affect oral medication;
* Patients with any severe and / or uncontrolled illness,
* Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding;
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT04612894
Study Brief:
Protocol Section:
NCT04612894