ClinConnect ClinConnect Logo
Search / Trial NCT07010393

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Launched by FUJIAN MEDICAL UNIVERSITY · Jun 1, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Locally Advanced Neoadjuvant Therapy Real World Study Braf V600 E Ret Fusion Vegf Tki Immunotherapy Conversion Surgery R0 Resection Precision Oncology Real World Evidence Conversion Therapy

ClinConnect Summary

This clinical trial is exploring a new way to treat advanced thyroid cancer that cannot be easily removed through surgery. Researchers want to see if a personalized treatment approach, using therapies matched to specific genetic features of the cancer, can make these tumors operable. Participants in the trial may receive 1 to 4 cycles of therapy designed to target certain genetic mutations, with the goal of shrinking the tumors enough to allow for surgery. The study will track how many patients can go on to have surgery, as well as their overall health outcomes over the next year.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of certain types of thyroid cancer that is considered too advanced or risky to operate on. They should have specific genetic markers that qualify them for the study. Participants will need to provide informed consent and will be monitored closely throughout the treatment process. It's important to note that the trial is not currently recruiting participants, but it aims to set a new standard for how to treat advanced thyroid tumors effectively.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥ 18 years at enrollment.
  • 2. Histologically or cytologically confirmed thyroid carcinoma that meets ≥ 1 of the following:
  • Radioactive-iodine-refractory differentiated thyroid carcinoma (DTC)
  • Medullary thyroid carcinoma (MTC)
  • Anaplastic or poorly differentiated thyroid carcinoma (ATC/PDTC)
  • Other locally advanced / metastatic thyroid malignancy deemed incurable by surgery alone.
  • 3. Disease judged unresectable or entailing prohibitively high-morbidity surgery at baseline by a multidisciplinary thyroid-oncology board.
  • 4. Documented molecular or immunophenotype qualifying for ≥ 1 study arm:
  • BRAF V600E mutation
  • RET gene fusion
  • RET activating point mutation (e.g., M918T)
  • NTRK1/2/3 fusion
  • Isolated TERT-promoter mutation with no BRAF/RET/NTRK alterations
  • Driver-negative / VEGFR-wild type ("triple-negative")
  • PD-L1 expression ≥ 1 % OR progression after prior multi-kinase inhibitor (MKI).
  • 5. ECOG Performance Status 0-2.
  • 6. At least one measurable lesion per RECIST v1.1 / iRECIST (MTC with calcitonin/CEA evaluable disease accepted).
  • 7. Written informed consent obtained.
  • Exclusion Criteria:
  • 1. Untreated or symptomatic CNS metastases; patients with treated, stable lesions ≥ 4 weeks and off corticosteroids are eligible.
  • 2. Pregnant or breastfeeding. Women and men of child-bearing potential must agree to effective contraception during study and for ≥ 120 days after last dose (≥ 180 days for men after dabrafenib/trametinib).

About Fujian Medical University

Fujian Medical University is a prestigious academic institution located in Fujian Province, China, dedicated to advancing medical education, research, and clinical practice. With a strong emphasis on innovative healthcare solutions, the university actively engages in clinical trials to explore new therapeutic interventions and improve patient outcomes. Its comprehensive research programs are supported by a team of experienced professionals and state-of-the-art facilities, enabling the university to contribute significantly to the global medical community. Through its commitment to excellence and collaboration, Fujian Medical University aims to enhance the quality of healthcare delivery both locally and internationally.

Locations

Fuzhou, Fujian, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported