The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 80
View:

• 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:

‣ Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection;

⁃ 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;

⁃ 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.

Locations
Other Locations
China
Fudan Univeristy Shanghai Cancer Center
RECRUITING
Shanghai
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 48
Treatments
None MTC
DTC, PDTC and ATC patients with RET fusions.
MTC
MTC patients with RET mutations
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov