A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
Overview
- Phase
- Phase 4
- Intervention
- dabrafenib plus trametinib with or without PD-1 antibody
- Conditions
- Advanced Thyroid Cancer Patients Who Received Target Therapy
- Sponsor
- Fudan University
- Enrollment
- 800
- Locations
- 8
- Primary Endpoint
- Objective Response Rate(ORR)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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 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.
Detailed Description
see:Arms and Interventions
Investigators
Ji Dongmei
Associated Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
Intervention: dabrafenib plus trametinib with or without PD-1 antibody
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
Intervention: entrectinib or larotrectinib with or without anti-PD-1 antibdoy
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
Intervention: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
Intervention: anlotinib or anlotinib plus anti-PD-1 antibody
Radioiodine-refractory differentiated thyroid cancer
advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
Intervention: lenvatinib plus anti-PD-1 antibody
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
Intervention: dabrafenib plus trametinib with or without PD-1 antibody
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
Intervention: entrectinib or larotrectinib with or without anti-PD-1 antibdoy
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
Intervention: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
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
Intervention: anlotinib or anlotinib plus anti-PD-1 antibody
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
Intervention: lenvatinib plus anti-PD-1 antibody
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
Intervention: dabrafenib plus trametinib with or without PD-1 antibody
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
Intervention: entrectinib or larotrectinib with or without anti-PD-1 antibdoy
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
Intervention: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
Intervention: anlotinib or anlotinib plus anti-PD-1 antibody
Medullary thyroid cancer
patients with advanced or metastatic medullary thyroid cancer
Intervention: lenvatinib plus anti-PD-1 antibody
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
Intervention: dabrafenib plus trametinib with or without PD-1 antibody
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
Intervention: entrectinib or larotrectinib with or without anti-PD-1 antibdoy
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
Intervention: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
Intervention: anlotinib or anlotinib plus anti-PD-1 antibody
High-grade or poorly differentiated thyroid cancer
patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
Intervention: lenvatinib plus anti-PD-1 antibody
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
Intervention: dabrafenib plus trametinib with or without PD-1 antibody
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
Intervention: entrectinib or larotrectinib with or without anti-PD-1 antibdoy
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
Intervention: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
Intervention: anlotinib or anlotinib plus anti-PD-1 antibody
Anaplastic thyroid cancer
patients with anaplastic thyroid cancer
Intervention: lenvatinib plus anti-PD-1 antibody
Outcomes
Primary Outcomes
Objective Response Rate(ORR)
Time Frame: up to approximately 3 years
Complete remission rate+ partial remission rate
Secondary Outcomes
- 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)