NCT07010393Not yet recruitingPhase 4
Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 335 (estimated)
- First submitted
- 28 May 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fujian Medical University
- Diseases
- Thyroid cancer
- NCT number
- NCT07010393
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 335
- From 1 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Untreated or symptomatic CNS metastases; patients with treated, stable lesions ≥ 4 weeks and off corticosteroids are eligible.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.