A Phase 4 interventional study of Dabrafenib and Trametinib in Thyroid Neoplasms, sponsored by Fujian Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Fujian Medical University · Phase 4, Interventional, and Treatment
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Among 16 studies in Thyroid Neoplasms by Fujian Medical University — 7 open to participants now, 7 under way, none of them phase 3. Thyroid Neoplasms · Fujian Medical University.
Among the 16 studies in Thyroid Neoplasms by Fujian Medical University, this one is one of 4 that started in 2025, is the only one in phase 4, and was the 11th registered.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
Browse Thyroid Neoplasms studies →7 of the 16 studies in Thyroid Neoplasms by Fujian Medical University are open now, in 1 country. Recruiting first, the newest first:
Fujian Medical University · Sites in China
Ages 14–80
Fujian Medical University · Sites in China
Fujian Medical University · Sites in China
Ages 18–65
Fujian Medical University · Sites in China
Fujian Medical University · Sites in China
Ages 18–80
By country, each count listing its studies:
Of the 152 Thyroid Neoplasms studies recruiting now, 96 (63%) set no upper age limit and 27 (18%) stop at 75 or younger; 37 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 335 is above the median of 54 across 520 interventional studies indexed under Thyroid Neoplasms.
Median enrollment 100 across the 9 interventional studies, 120 across the 7 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.
1 of the studies in Thyroid Neoplasms by Fujian Medical University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07628543Fujian Medical UniversityComputer Vision-Based Recognition of Parathyroid Glands and Recurrent Laryngeal Nerves in Endoscopic Surgery | 2027-05-31 |
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Among the 16 studies in Thyroid Neoplasms by Fujian Medical University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
This multicenter, prospective-retrospective registry will determine whether genotype-matched neoadjuvant systemic therapy can convert locally advanced, initially unresectable or high-morbidity thyroid cancers to successful surgery. Patients receive one to four 28-day cycles of treatment chosen according to actionable genomic alterations-BRAF V600E, RET fusion, RET point mutation, isolated TERT promoter mutation, "BRT triple-negative" (wild-type for BRAF/RET/TERT), or immune-checkpoint blockade ± TKI-before reassessment by a multidisciplinary team.
Primary outcome is the conversion-to-surgery rate. Key secondary outcomes include R0/1 (margin-negative) resection rate and 12-month event-free survival, defined as absence of progression, unresectability at planned surgery, recurrence, or death. Propensity-score weighting will balance baseline differences among cohorts and permit adjusted comparisons. Results will clarify the role of targeted and immunologic agents in down-staging advanced thyroid tumors and may establish a precision-guided neoadjuvant standard of care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
or cytologically confirmed thyroid carcinoma that meets ≥ 1 of the following:
Documented molecular or immunophenotype qualifying for ≥ 1 study arm:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dabrafenib 150 mg PO BID + trametinib 2 mg PO QD given in 28-day cycles (Day 1-28). After Cycle 4 (Day 112 ± 7) patients undergo imaging review; if previously unresectable disease becomes operable, conversion surgery is scheduled within 3 weeks. Those still unresectable continue treatment until progression/toxicity.
Drug: Dabrafenib · Drug: Trametinib · Drug: Lenvatinib · Drug: Anlotinib · Drug: Cabozantinib · Procedure: Conversion Surgery
Selpercatinib 160 mg PO BID, continuous 28-day cycles. Surgery conversion assessment at Day 112 (end of Cycle 4). Resectable cases proceed to thyroidectomy ± neck dissection; others maintain therapy per label.
Drug: Selpercatinib · Drug: Pralsetinib · Drug: Lenvatinib · Drug: Anlotinib · Drug: Cabozantinib · Procedure: Conversion Surgery
Prospective cohort: selpercatinib 160 mg PO BID, 28-day cycles; Retrospective sub-cohort: historical pralsetinib 400 mg PO QD (also 28-day cycles). Cycle 4 reassessment (Day 112) for potential curative resection of residual neck disease or distant oligometastases.
Drug: Selpercatinib · Drug: Lenvatinib · Drug: Anlotinib · Drug: Cabozantinib · Procedure: Conversion Surgery
Larotrectinib 100 mg PO BID in continuous 28-day cycles with multidisciplinary resectability evaluation after 4 cycles (Day 112). Eligible patients undergo surgery; non-eligible continue TRK inhibitor.
Drug: Lenvatinib · Drug: Larotrectinib · Drug: Anlotinib · Drug: Cabozantinib · Procedure: Conversion Surgery
Investigator-selected MKI: lenvatinib 24 mg PO QD (28-day cycle), anlotinib 12 mg PO d1-14 q21d (21-day cycle; Cycle 4 ends Day 84), or cabozantinib 60 mg PO QD (28-day cycle). Conversion-surgery review: Day 112 for 28-day regimens or Day 84 for anlotinib.
Drug: Lenvatinib · Drug: Anlotinib · Drug: Pembrolizumab · Drug: Sintilimab · Drug: Cabozantinib · Drug: Bemosuzumab · Procedure: Conversion Surgery
Same MKI options/cycle lengths as Arm 5. Cycle 4 resectability check (Day 112 or Day 84 depending on drug). Successful conversions proceed to definitive surgery; others remain on systemic therapy.
Drug: Trametinib · Drug: Lenvatinib · Drug: Anlotinib · Drug: Pembrolizumab · Drug: Sintilimab · Drug: Cabozantinib · Drug: Bemosuzumab · Procedure: Conversion Surgery
Checkpoint agents: pembrolizumab 200 mg IV q3w (21-day cycles), sintilimab 200 mg IV q3w (21 d), or domestic PD-L1 Ab bemosuzumab 900 mg IV q2w (14-day cycles). Combination option: lenvatinib 20 mg PO QD (28-day cycles) added at investigator discretion. Conversion assessment occurs after 4 cycles of the longest component being used (e.g., Day 84 for pembrolizumab; Day 112 if combined with 28-day MKI). Resectable patients undergo surgery; others continue or switch therapy.
Drug: Lenvatinib · Drug: Anlotinib · Drug: Pembrolizumab · Drug: Sintilimab · Drug: Cabozantinib · Drug: Bemosuzumab · Procedure: Conversion Surgery
150 mg orally twice daily; ≤4 × 28-day cycles
2 mg orally once daily; same duration
160 mg orally twice daily; ≤4 cycles
retrospective, 400 mg orally once daily; ≤4 cycles
24 mg orally once daily; ≤4 cycles
Larotrectinib 100 mg orally twice daily, continuous 28-day cycles.
12 mg orally once daily; 2 weeks on / 1 week off, ≤4 cycles (alternative)
200 mg IV infusion every 3 weeks; ≤4 cycles
200 mg IV infusion every 3 weeks; ≤4 cycles
Cabozantinib 60 mg orally once daily, continuous 28-day cycles.
China PD-L1 antibody bemosuzumab 900 mg IV every 2 weeks (14-day cycle).
Conversion Surgery if resectable
Real-World Progression-Free Survival (rwPFS)
Time from Cycle 1 Day 1 to the earliest date of disease progression (RECIST/iRECIST) or all-cause death.
Time frame: Baseline to radiologic/clinical progression or death, whichever occurs first, up to 36 months
Real-World Objective Response Rate (rwORR)
Percentage of patients with complete or partial response per RECIST v1.1 (or iRECIST for immunotherapy arms) as determined by local radiology.
Time frame: Baseline to first documented response, assessed every 8-12 weeks, up to 24 months
Pathologic Tumor Regression ≥ 50 %
Proportion of surgical specimens showing ≥ 50 % reduction in viable tumor area compared with baseline imaging estimate.
Time frame: At surgery
R0/1 Resection Rate
Percentage of resected participants whose final pathology shows microscopically negative (R0) or close (R1 ≤ 1 mm) margins.
Time frame: At surgery (≈ 1-5 months after first dose)
Conversion-to-Surgery Rate
Proportion of enrolled participants who proceed to the intended curative-intent resection after completion of neoadjuvant therapy.
Time frame: Up to 12 months from first dose
Overall Survival (OS)
Time from Cycle 1 Day 1 to death; survivors censored at last known follow-up.
Time frame: Baseline to death from any cause, censored at 36 months
Duration of Response (DoR)
Among responders, time between initial response and subsequent disease progression or death.
Time frame: From first documented response until progression or death, up to 36 months
Incidence of Grade ≥ 3 Treatment-Related AEs
Number and percentage of participants experiencing Grade 3 or higher adverse events per CTCAE v5.0.
Time frame: Baseline to 30 days after last dose
Quality-of-Life Change (EORTC QLQ-THY34)
Mean change from baseline in global QoL score.
Time frame: Baseline, pre-surgery, and 6 months post-surgery
Thyroglobulin Reduction ≥ 90 %
Proportion of differentiated-tumor participants with ≥ 90 % decrease in serum thyroglobulin from baseline.
Time frame: Pre-surgery (≈ 4 months)
Plan to share: Undecided — De-identified datasets will be available 6 months after primary publication via institutional repository upon reasonable request
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Dec 2027, 29 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dabrafenib · Trametinib · Selpercatinib · Pralsetinib · Lenvatinib · Larotrectinib · Anlotinib · Sintilimab · Cabozantinib