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

Recruiting

• Conditions: Thyroid Cancer
• Interventions: Drug: RET Inhibitor; Procedure: Surgery

• Registration Number: NCT06530316
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-18
• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-07-27
• Study First Posted: 2024-07-31
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
None MTC	RET Inhibitor	DTC, PDTC and ATC patients with RET fusions.
None MTC	Surgery	DTC, PDTC and ATC patients with RET fusions.
MTC	RET Inhibitor	MTC patients with RET mutations
MTC	Surgery	MTC patients with RET mutations

Primary Outcome Measures

Name	Time	Method
R0/1 resection rate	1 year

Secondary Outcome Measures

Name	Time	Method
Time to objective response，TTR	1 year
Objective Response Rate, ORR	1 year
Progression Free Survival，PFS	5 years
Overall Survival，OS	5 years
Disease Control Rate，DCR	1 year
Adverse Events	During RET inhibitor treatment, up to 5 years

Trial Locations

Locations (1)

Fudan Univeristy Shanghai Cancer Center; 🇨🇳 Shanghai, China