NCT06530316 RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer
| NCT ID | NCT06530316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Thyroid Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2024-07-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.
Eligibility Criteria
Inclusion Criteria: * Patients voluntarily join this study and sign an informed consent form; * Age: ≥ 14 years old, male or female not limited; * Locally advanced thyroid cancer diagnosed by histopathology, including papillary thyroid carcinoma, medullary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated/poorly differentiated thyroid carcinoma, etc; * RET alterations, including fusion and mutations; * The definition of locally advanced thyroid cancer meets at least one of the following criteria: 1. Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection; 2. T4 thyroid cancer defined by AJCC: any size of tumor primary lesion or regional lymph node infiltration beyond the thyroid capsule to subcutaneous soft tissue, larynx, trachea, esophagus, or recurrent laryngeal nerve, tumor invasion of pre vertebral fascia or wrapping around carotid or mediastinal blood vessels; 3. According to the imaging score, the resectable probability is less than 80% based on CT. * At least one measurable lesion; * For patients with distant metastasis, researchers need to determine whether patients would benefit from surgery; * Patients voluntarily undergo tumor tissue biopsy/surgery during enrollment and withdrawal; * Normal function of major organs. Exclusion Criteria: * Previously used RET inhibitors; * There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction; * The patient refuses to undergo tumor tissue biopsy or surgery; * Patients who are unsuitable for RET inhibitors or surgery.
Frequently Asked Questions
Who can join the NCT06530316 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06530316 currently recruiting?
Yes, NCT06530316 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fudan University to inquire about joining.
Where is the NCT06530316 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06530316 clinical trial?
NCT06530316 is sponsored by Fudan University. The trial plans to enroll 48 participants.
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