Advanced Thyroid Cancer Patients Who Received Target Therapy
Conditions
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
Interventions
DRUGdabrafenib plus trametinib with or without PD-1 antibody
advanced thyroid cancer patients who harbor BRAF V600E mutation
DRUGentrectinib or larotrectinib with or without anti-PD-1 antibdoy
advanced thyroid cancer patients who harbor NTRK mutation
DRUGpralsetinib or selpercatinib with or without anti-PD-1 antibdoy
advanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation.
DRUGanlotinib or anlotinib plus anti-PD-1 antibody
For patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown
DRUGlenvatinib plus anti-PD-1 antibody
Advanced thyroid cancer patients who don't harbor the above gene mutation or could not afford the cost of precision treatment even with the above gene mutation
DRUGOther Targets: precise treatment based on the target
Advanced thyroid cancer patients who had other treatment targets not included above
Sponsors
Peking Union Medical College Hospital
Shanxi Province Cancer Hospital
Henan Cancer Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zhejiang Cancer Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Ruijin Hospital
Fujian Cancer Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shanghai 6th People's Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai 10th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Changhai Hospital
Tianjin Medical University Cancer Institute and Hospital
Jiangsu Cancer Institute & Hospital
The First Affiliated Hospital of Anhui University of Chinese Medicine
Hunan Provincial People's Hospital
Dalian Friendship Hospital Affiliated to Dalian Medical University
The Third Affiliated Hospital of Soochow University
Sun Yat-sen University
Liaoning Cancer Hospital & Institute
Sir Run Run Shaw Hospital
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients volunteered to participate in this study and signed informed consent; 2. Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ; 3. Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements: 1. Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC); 2. Differentiated thyroid carcinoma not suitable for iodine therapy; 3. Medullary thyroid carcinoma (MTC); 4. poorly differentiated thyroid cancer (PDTC) or anaplastic thyroid cancer (ATC); 4. Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.
Exclusion criteria
1. Patients who are participating in clinical trials of other drugs; 2. There is evidence that the patients are pregnant or lactating; 3. Other situations that are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | up to approximately 3 years | Complete remission rate+ partial remission rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactDongmei Ji, M.D
Outcome results
None listed