NCT06530316招募中不适用
The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- R0/1 resection rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
None MTC
DTC, PDTC and ATC patients with RET fusions.
干预措施: RET Inhibitor (Drug)
None MTC
DTC, PDTC and ATC patients with RET fusions.
干预措施: Surgery (Procedure)
MTC
MTC patients with RET mutations
干预措施: RET Inhibitor (Drug)
MTC
MTC patients with RET mutations
干预措施: Surgery (Procedure)
结局指标
主要结局
R0/1 resection rate
时间窗: 1 year
次要结局
- 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)
- Time to objective response，TTR(1 year)
研究者
Yu Wang
Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center
Fudan University
研究点 (1)
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