Using RET inhibitors before surgery for advanced thyroid cancer
The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study
This study is testing whether using RET inhibitors before surgery can help people with advanced thyroid cancer that has specific genetic changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06530316 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study evaluates the use of RET inhibitors as neoadjuvant therapy in patients with locally advanced RET-altered thyroid cancer. Participants who respond to the treatment may proceed to surgical intervention. The study aims to assess both the efficacy and safety of this approach in a real-world setting, focusing on various types of thyroid cancer that exhibit RET alterations. By monitoring patient outcomes, the study seeks to provide insights into the potential benefits of this treatment strategy.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 and older with locally advanced RET-altered thyroid cancer.
Not a fit: Patients with thyroid cancer that does not exhibit RET alterations or those who are not eligible for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival for patients with advanced thyroid cancer.
How similar studies have performed: While this approach is novel in the context of neoadjuvant therapy for RET-altered thyroid cancer, similar studies with targeted therapies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Fudan Univeristy Shanghai Cancer Center — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.