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

Fudan University

Status and phase: Enrolling; Phase 4

Conditions: Advanced Thyroid Cancer Patients Who Received Target Therapy

Treatments: Drug: Other Targets: precise treatment based on the target; Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: lenvatinib plus anti-PD-1 antibody; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: anlotinib or anlotinib plus anti-PD-1 antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT06195228

FUSCC-TC-RWS01

Details and patient eligibility

About

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.

Full description

see:Arms and Interventions

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 5 patient groups

Radioiodine-refractory differentiated thyroid cancer

Experimental group

Description:

advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment

Treatment:

Drug: anlotinib or anlotinib plus anti-PD-1 antibody

Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy

Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy

Drug: lenvatinib plus anti-PD-1 antibody

Drug: Other Targets: precise treatment based on the target

Drug: dabrafenib plus trametinib with or without PD-1 antibody

Differentiated thyroid carcinoma not suitable for radioiodine therapy

Experimental group

Description:

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

Treatment:

Drug: anlotinib or anlotinib plus anti-PD-1 antibody

Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy

Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy

Drug: lenvatinib plus anti-PD-1 antibody

Drug: Other Targets: precise treatment based on the target

Drug: dabrafenib plus trametinib with or without PD-1 antibody

Medullary thyroid cancer

Experimental group

Description:

patients with advanced or metastatic medullary thyroid cancer

Treatment:

Drug: anlotinib or anlotinib plus anti-PD-1 antibody

Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy

Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy

Drug: lenvatinib plus anti-PD-1 antibody

Drug: Other Targets: precise treatment based on the target

Drug: dabrafenib plus trametinib with or without PD-1 antibody

High-grade or poorly differentiated thyroid cancer

Experimental group

Description:

patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer

Treatment:

Drug: anlotinib or anlotinib plus anti-PD-1 antibody

Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy

Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy

Drug: lenvatinib plus anti-PD-1 antibody

Drug: Other Targets: precise treatment based on the target

Drug: dabrafenib plus trametinib with or without PD-1 antibody

Anaplastic thyroid cancer

Experimental group

Description:

patients with anaplastic thyroid cancer

Treatment:

Drug: anlotinib or anlotinib plus anti-PD-1 antibody

Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy

Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy

Drug: lenvatinib plus anti-PD-1 antibody

Drug: Other Targets: precise treatment based on the target

Drug: dabrafenib plus trametinib with or without PD-1 antibody