A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer

Обзор

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.

Подробное описание

see:Arms and Interventions

Вмешательства

• Препарат dabrafenib plus trametinib with or without PD-1 antibody
  advanced thyroid cancer patients who harbor BRAF V600E mutation
• Препарат entrectinib or larotrectinib with or without anti-PD-1 antibdoy
  advanced thyroid cancer patients who harbor NTRK mutation
• Препарат pralsetinib 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.
• Препарат anlotinib 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
• Препарат lenvatinib 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
• Препарат Other Targets: precise treatment based on the target
  Advanced thyroid cancer patients who had other treatment targets not included above

Первичные конечные точки

• Objective Response Rate(ORR) [Срок оценки: up to approximately 3 years]

Вторичные конечные точки (5)

• Duration of Response(DOR) [Срок оценки: up to approximately 3 years]
• Disease Control Rate(DCR) [Срок оценки: up to approximately 3 years]
• Time to response(TTR) [Срок оценки: up to approximately 3 years]
• Progression Free Survival(PFS) [Срок оценки: up to approximately 3 years]
• Overall survival(OS) [Срок оценки: up to approximately 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 8 центров

• Fujian Cancer Hospital — Фучжоу
• Henan Cancer Hospital — Чжэнчжоу
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
• Caixia Liu — Hohhot
• Fudan University Shanghai Cancer Center — Шанхай
• Shanxi Cancer Hospital — Shanxi
• Zhejiang Cancer Hospital — Ханчжоу
• Peking union medical college hospital — Пекин

Идентификаторы

NCT: NCT06195228 · FUSCC-TC-RWS01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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