A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
- Conditions
- Advanced Thyroid Cancer Patients Who Received Target Therapy
- Interventions
- Registration Number
- NCT06195228
- Lead Sponsor
- Fudan University
- Brief Summary
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 our hospital 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 our hospital from January 2024 to April 2027 were enrolled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
Patients volunteered to participate in this study and signed informed consent;
-
Age: ≥ 18 years old, male or female;
-
Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:
- Radioiodine-refractory thyroid cancer;
- Differentiated thyroid carcinoma not suitable for iodine therapy;
- Medullary thyroid carcinoma;
- High-grade or poorly differentiated thyroid cancer;
- Anaplastic thyroid cancer;
-
Patients who had undergone NGS testing (in our hospital or other hospitals) were able to query the test report or the key genetic test results recorded in the medical history (such as BRAF, RET, NTRK and other genetic test results).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radioiodine-refractory differentiated thyroid cancer anlotinib or anlotinib plus anti-PD-1 antibody advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment Anaplastic thyroid cancer anlotinib or anlotinib plus anti-PD-1 antibody patients with anaplastic thyroid cancer Radioiodine-refractory differentiated thyroid cancer lenvatinib plus anti-PD-1 antibody advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment Radioiodine-refractory differentiated thyroid cancer entrectinib or larotrectinib with or without anti-PD-1 antibdoy advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment Differentiated thyroid carcinoma not suitable for radioiodine therapy dabrafenib plus trametinib with or without PD-1 antibody 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 Differentiated thyroid carcinoma not suitable for radioiodine therapy entrectinib or larotrectinib with or without anti-PD-1 antibdoy 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 Differentiated thyroid carcinoma not suitable for radioiodine therapy pralsetinib or selpercatinib with or without anti-PD-1 antibdoy 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 Differentiated thyroid carcinoma not suitable for radioiodine therapy anlotinib or anlotinib plus anti-PD-1 antibody 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 Differentiated thyroid carcinoma not suitable for radioiodine therapy lenvatinib plus anti-PD-1 antibody 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 Medullary thyroid cancer entrectinib or larotrectinib with or without anti-PD-1 antibdoy patients with advanced or metastatic medullary thyroid cancer Medullary thyroid cancer pralsetinib or selpercatinib with or without anti-PD-1 antibdoy patients with advanced or metastatic medullary thyroid cancer Medullary thyroid cancer lenvatinib plus anti-PD-1 antibody patients with advanced or metastatic medullary thyroid cancer High-grade or poorly differentiated thyroid cancer pralsetinib or selpercatinib with or without anti-PD-1 antibdoy patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer Anaplastic thyroid cancer entrectinib or larotrectinib with or without anti-PD-1 antibdoy patients with anaplastic thyroid cancer Anaplastic thyroid cancer pralsetinib or selpercatinib with or without anti-PD-1 antibdoy patients with anaplastic thyroid cancer High-grade or poorly differentiated thyroid cancer dabrafenib plus trametinib with or without PD-1 antibody patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer Radioiodine-refractory differentiated thyroid cancer pralsetinib or selpercatinib with or without anti-PD-1 antibdoy advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment Medullary thyroid cancer dabrafenib plus trametinib with or without PD-1 antibody patients with advanced or metastatic medullary thyroid cancer Radioiodine-refractory differentiated thyroid cancer dabrafenib plus trametinib with or without PD-1 antibody advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment Medullary thyroid cancer anlotinib or anlotinib plus anti-PD-1 antibody patients with advanced or metastatic medullary thyroid cancer High-grade or poorly differentiated thyroid cancer entrectinib or larotrectinib with or without anti-PD-1 antibdoy patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer Anaplastic thyroid cancer dabrafenib plus trametinib with or without PD-1 antibody patients with anaplastic thyroid cancer High-grade or poorly differentiated thyroid cancer anlotinib or anlotinib plus anti-PD-1 antibody patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer High-grade or poorly differentiated thyroid cancer lenvatinib plus anti-PD-1 antibody patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer Anaplastic thyroid cancer lenvatinib plus anti-PD-1 antibody patients with anaplastic thyroid cancer
- Primary Outcome Measures
Name Time Method Objective Response Rate(ORR) up to approximately 3 years Complete remission rate+ partial remission rate
- Secondary Outcome Measures
Name Time Method Duration of Response(DOR) up to approximately 3 years Time from the date of first partial remission or complete remission to the date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Disease Control Rate(DCR) up to approximately 3 years Complete remission rate+ partial remission rate+stable disease rate
Time to response(TTR) up to approximately 3 years Time from the initiation of the treatment to the first remission
Progression Free Survival(PFS) up to approximately 3 years Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Overall survival(OS) up to approximately 3 years Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Trial Locations
- Locations (3)
Shanxi Cancer Hospital
🇨🇳Shanxi, Taiyuan, China
Caixia Liu
🇨🇳Hohhot, Inner Mongolia, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China