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

NCT ID: NCT06530316

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2029-12-31

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.

Conditions

Thyroid Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

None MTC

DTC, PDTC and ATC patients with RET fusions.

RET Inhibitor

Intervention Type: DRUG

RET inhibitors for neoadjuvant treatment

Surgery

Intervention Type: PROCEDURE

Operable patients receive surgery after neoadjuvant therapy

MTC

MTC patients with RET mutations

RET Inhibitor

Intervention Type: DRUG

RET inhibitors for neoadjuvant treatment

Surgery

Intervention Type: PROCEDURE

Operable patients receive surgery after neoadjuvant therapy

Interventions

RET Inhibitor

RET inhibitors for neoadjuvant treatment

Intervention Type: DRUG

Surgery

Operable patients receive surgery after neoadjuvant therapy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Yu Wang

Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan Univeristy Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yu Wang, M.D.

Role: primary

neck130@hotmail.com

86-021-64175590 ext. 65805

Other Identifiers

PATHYOID

Identifier Type: -

Identifier Source: org_study_id