RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RET Inhibitor, Surgery.
- Who it may be relevant to
- Registry conditions: Thyroid Cancer. Basic parameters: 14 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study
Overview
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.
Interventions
- Drug RET Inhibitor
RET inhibitors for neoadjuvant treatment - Procedure Surgery
Operable patients receive surgery after neoadjuvant therapy
Primary outcome measures
- R0/1 resection rate [Time frame: 1 year]
Secondary outcome measures (6)
- Objective Response Rate, ORR [Time frame: 1 year]
- Disease Control Rate，DCR [Time frame: 1 year]
- Time to objective response，TTR [Time frame: 1 year]
- Progression Free Survival，PFS [Time frame: 5 years]
- Overall Survival，OS [Time frame: 5 years]
- Adverse Events [Time frame: During RET inhibitor treatment, up to 5 years]
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:
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan Univeristy Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06530316 · PATHYOID