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

Sponsor
Fudan University
Study ID
NCT06195228
Phase
PHASE4
Status
Recruiting
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Conditions

  • Advanced Thyroid Cancer Patients Who Received Target Therapy

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • dabrafenib plus trametinib with or without PD-1 antibody — DRUG
    advanced thyroid cancer patients who harbor BRAF V600E mutation
  • entrectinib or larotrectinib with or without anti-PD-1 antibdoy — DRUG
    advanced thyroid cancer patients who harbor NTRK mutation
  • pralsetinib or selpercatinib with or without anti-PD-1 antibdoy — DRUG
    advanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation.
  • anlotinib or anlotinib plus anti-PD-1 antibody — DRUG
    For patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown
  • lenvatinib plus anti-PD-1 antibody — DRUG
    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
  • Other Targets: precise treatment based on the target — DRUG
    Advanced thyroid cancer patients who had other treatment targets not included above

Study Details

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.

Key Dates

Start date
Jan 1, 2020
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radioiodine-refractory differentiated thyroid cancer
    advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment
  • Experimental: 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
  • Experimental: Medullary thyroid cancer
    patients with advanced or metastatic medullary thyroid cancer
  • Experimental: High-grade or poorly differentiated thyroid cancer
    patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer
  • Experimental: Anaplastic thyroid cancer
    patients with anaplastic thyroid cancer

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: up to approximately 3 years ]

Central Contacts