A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 8
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer.
The retrospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 participated hospitals from January 2020 to December 2023 were retrieved. The number of previous treatment lines was not limited. Patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. Demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected.
The prospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 Chinese hospitals from January 2024 to April 2027 were enrolled.
详细描述
see:Arms and Interventions
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients volunteered to participate in this study and signed informed consent;
- •Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ;
- •Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:
- •Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC);
- •Differentiated thyroid carcinoma not suitable for iodine therapy;
- •Medullary thyroid carcinoma (MTC);
- •poorly differentiated thyroid cancer (PDTC) or anaplastic thyroid cancer (ATC);
- •Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.
排除标准
- •Patients who are participating in clinical trials of other drugs;
- •There is evidence that the patients are pregnant or lactating;
- •Other situations that are not suitable for inclusion in this study.
研究组 & 干预措施
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
干预措施: dabrafenib plus trametinib with or without PD-1 antibody (Drug)
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
干预措施: entrectinib or larotrectinib with or without anti-PD-1 antibdoy (Drug)
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
干预措施: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy (Drug)
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
干预措施: anlotinib or anlotinib plus anti-PD-1 antibody (Drug)
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
干预措施: lenvatinib plus anti-PD-1 antibody (Drug)
Differentiated thyroid carcinoma not suitable for radioiodine therapy
advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy
干预措施: dabrafenib plus trametinib with or without PD-1 antibody (Drug)
Differentiated thyroid carcinoma not suitable for radioiodine therapy
advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy
干预措施: entrectinib or larotrectinib with or without anti-PD-1 antibdoy (Drug)
Differentiated thyroid carcinoma not suitable for radioiodine therapy
advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy
干预措施: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy (Drug)
Differentiated thyroid carcinoma not suitable for radioiodine therapy
advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy
干预措施: anlotinib or anlotinib plus anti-PD-1 antibody (Drug)
Differentiated thyroid carcinoma not suitable for radioiodine therapy
advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy
干预措施: lenvatinib plus anti-PD-1 antibody (Drug)
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
干预措施: dabrafenib plus trametinib with or without PD-1 antibody (Drug)
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
干预措施: entrectinib or larotrectinib with or without anti-PD-1 antibdoy (Drug)
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
干预措施: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy (Drug)
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
干预措施: anlotinib or anlotinib plus anti-PD-1 antibody (Drug)
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
干预措施: lenvatinib plus anti-PD-1 antibody (Drug)
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
干预措施: dabrafenib plus trametinib with or without PD-1 antibody (Drug)
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
干预措施: entrectinib or larotrectinib with or without anti-PD-1 antibdoy (Drug)
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
干预措施: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy (Drug)
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
干预措施: anlotinib or anlotinib plus anti-PD-1 antibody (Drug)
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
干预措施: lenvatinib plus anti-PD-1 antibody (Drug)
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
干预措施: dabrafenib plus trametinib with or without PD-1 antibody (Drug)
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
干预措施: entrectinib or larotrectinib with or without anti-PD-1 antibdoy (Drug)
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
干预措施: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy (Drug)
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
干预措施: anlotinib or anlotinib plus anti-PD-1 antibody (Drug)
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
干预措施: lenvatinib plus anti-PD-1 antibody (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: up to approximately 3 years
Complete remission rate+ partial remission rate
次要结局
- Duration of Response(DOR)(up to approximately 3 years)
- Disease Control Rate(DCR)(up to approximately 3 years)
- Time to response(TTR)(up to approximately 3 years)
- Progression Free Survival(PFS)(up to approximately 3 years)
- Overall survival(OS)(up to approximately 3 years)
研究者
Ji Dongmei
Associated Professor
Fudan University