RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer

Launched by FUDAN UNIVERSITY · Jul 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a specific type of thyroid cancer called RET-altered thyroid cancer. In this study, patients will receive a medication known as RET inhibitors before surgery, which is called neoadjuvant therapy. The goal is to see how effective and safe these medications are in shrinking tumors that are difficult to operate on, making surgery easier and more successful.

To be eligible for this trial, participants must be at least 14 years old and have a diagnosis of locally advanced thyroid cancer with certain genetic changes known as RET alterations. They should have tumors that are challenging to remove surgically or have other factors that make surgery risky. If you join the study, you will receive the RET inhibitor treatment and, if your doctors think it's safe and effective, you may have surgery afterward. Before joining, you'll need to agree to a biopsy, which is a small procedure to take a sample of the tumor. This study is currently looking for participants, and it is open to both males and females.

Gender

ALL

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.