Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
Key facts
- Where
- Fuzhou, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07010393, who can take part
Where in China
- Fujian Medical University Union HospitalFuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Medical University
- Trial code
- NCT07010393
- Record updated
- 8 June 2025
- Original description
This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.Read full original descriptionShow less
A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma
This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.
Inclusion: Age ≥ 18 years at enrollment; 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; Disease judged unresectable or entailing prohibitively high-morbidity surgery at baseline by a multidisciplinary thyroid-oncology board; 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); ECOG Performance Status 0-2; At least one measurable lesion per RECIST v1.1 / iRECIST (MTC with calcitonin/CEA evaluable disease accepted); Written informed consent obtained.
Exclusion: Untreated or symptomatic CNS metastases; patients with treated, stable lesions ≥ 4 weeks and off corticosteroids are eligible; 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).