Thyroid NeoplasmsPhase 4NCT07010393
Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
A Phase 4 study testing Dabrafenib, Trametinib and Selpercatinib in people with Thyroid Neoplasms, run by Fujian Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Dabrafenib, Trametinib and Selpercatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bo Wang Porfessor, MD, wangbo@fjmu.edu.cn
Bo Wang MD, Principal Investigator
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Thyroid Neoplasms
- Being tested
- Dabrafenib, Trametinib, Selpercatinib, Pralsetinib, Lenvatinib
- Keywords
- Locally Advanced, Neoadjuvant Therapy, Real-World Study, BRAF V600E, RET Fusion, VEGF-TKI, Immunotherapy, Conversion Surgery, R0 Resection, Precision Oncology, Real-World Evidence, Conversion Therapy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
150 mg orally twice daily; ≤4 × 28-day cycles
TrametinibDrug
2 mg orally once daily; same duration
SelpercatinibDrug
160 mg orally twice daily; ≤4 cycles
PralsetinibDrug
retrospective, 400 mg orally once daily; ≤4 cycles
LenvatinibDrug
24 mg orally once daily; ≤4 cycles
LarotrectinibDrug
Larotrectinib 100 mg orally twice daily, continuous 28-day cycles.
AnlotinibDrug
12 mg orally once daily; 2 weeks on / 1 week off, ≤4 cycles (alternative)
PembrolizumabDrug
200 mg IV infusion every 3 weeks; ≤4 cycles
SintilimabDrug
200 mg IV infusion every 3 weeks; ≤4 cycles
CabozantinibDrug
Cabozantinib 60 mg orally once daily, continuous 28-day cycles.
BemosuzumabDrug
China PD-L1 antibody bemosuzumab 900 mg IV every 2 weeks (14-day cycle).
Conversion SurgeryProcedure or surgery
Conversion Surgery if resectable
| Study group | Role | What they receive |
|---|---|---|
| BRAF V600E Mutation | Experimental | 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. Receives: Drug: Dabrafenib; Drug: Trametinib; Drug: Lenvatinib; Drug: Anlotinib; Drug: Cabozantinib; Procedure: Conversion Surgery |
| RET Fusion PTC | Experimental | 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. Receives: Drug: Selpercatinib; Drug: Pralsetinib; Drug: Lenvatinib; Drug: Anlotinib; Drug: Cabozantinib; Procedure: Conversion Surgery |
| RET Point-Mutation MTC | Experimental | 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. Receives: Drug: Selpercatinib; Drug: Lenvatinib; Drug: Anlotinib; Drug: Cabozantinib; Procedure: Conversion Surgery |
| NTRK Fusion | Experimental | 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. Receives: Drug: Lenvatinib; Drug: Larotrectinib; Drug: Anlotinib; Drug: Cabozantinib; Procedure: Conversion Surgery |
| TERT-Only (MKI) | Experimental | 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. Receives: Drug: Lenvatinib; Drug: Anlotinib; Drug: Pembrolizumab; Drug: Sintilimab; Drug: Cabozantinib; Drug: Bemosuzumab; Procedure: Conversion Surgery |
| Triple-Negative (driver-negative) - MKI | Experimental | 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. Receives: Drug: Trametinib; Drug: Lenvatinib; Drug: Anlotinib; Drug: Pembrolizumab; Drug: Sintilimab; Drug: Cabozantinib; Drug: Bemosuzumab; Procedure: Conversion Surgery |
| PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI | Experimental | 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. Receives: Drug: Lenvatinib; Drug: Anlotinib; Drug: Pembrolizumab; Drug: Sintilimab; Drug: Cabozantinib; Drug: Bemosuzumab; Procedure: Conversion Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to radiologic/clinical progression or death, whichever occurs first, up to 36 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: At surgery
R0/1 Resection Rate
Percentage of resected participants whose final pathology shows microscopically negative (R0) or close (R1 ≤ 1 mm) margins.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 30 days after last dose
Quality-of-Life Change (EORTC QLQ-THY34)
Mean change from baseline in global QoL score.
Measured: Baseline, pre-surgery, and 6 months post-surgery
Thyroglobulin Reduction ≥ 90 %
Proportion of differentiated-tumor participants with ≥ 90 % decrease in serum thyroglobulin from baseline.
Measured: Pre-surgery (≈ 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to seven genotype- or immunophenotype-defined, parallel, non-overlapping arms with no planned cross-over: Arm 1 (BRAF V600E) - dabrafenib + trametinib Arm 2 (RET fusion) - selpercatinib Arm 3 (RET point-mutation MTC) - selpercatinib or retrospective cohort on pralsetinib Arm 4 (NTRK fusion) - larotrectinib Arm 5 (TERT-only, driver-negative for BRAF/RET) - lenvatinib, anlotinib, or cabozantinib Arm 6 (Triple-negative, no actionable driver) - investigator-choice MKI (lenvatinib, anlotinib, cabozantinib) Arm 7 (PD-L1 ≥ 1 % or MKI-refractory) - PD-1/PD-L1 blockade (pembrolizumab, sintilimab, or domestic PD-L1 antibody bemosuzumab) ± MKI combination (e.g., pembrolizumab + lenvatinib) per treating physician Assignment is open-label, non-randomized; placement into an arm is decided before first dose by a central molecular \& PD-L1 board reviewing NGS/PCR and IHC results. No cross-over permitted.
- Masking
- None (open label)
- Enrolment
- 335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010393
- Sponsor's protocol ID
- Real-Neo
- Status last verified
- Jan 2025
- First submitted
- 28 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified datasets will be available 6 months after primary publication via institutional repository upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT07010393
- Acronym / sponsor ID
- Real-Neo
- Conditions
- Thyroid Neoplasms
- Keywords
- Locally Advanced, Neoadjuvant Therapy, Real-World Study, BRAF V600E, RET Fusion, VEGF-TKI, Immunotherapy, Conversion Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Participants are assigned to seven genotype- or immunophenotype-defined, parallel, non-overlapping arms with no planned cross-over: Arm 1 (BRAF V600E) - dabrafenib + trametinib Arm 2 (RET fusion) - selpercatinib Arm 3 (RET point-mutation MTC) - selpercatinib or retrospective cohort on pralsetinib Arm 4 (NTRK fusion) - larotrectinib Arm 5 (TERT-only, driver-negative for BRAF/RET) - lenvatinib, anlotinib, or cabozantinib Arm 6 (Triple-negative, no actionable driver) - investigator-choice MKI (lenvatinib, anlotinib, cabozantinib) Arm 7 (PD-L1 ≥ 1 % or MKI-refractory) - PD-1/PD-L1 blockade (pembrolizumab, sintilimab, or domestic PD-L1 antibody bemosuzumab) ± MKI combination (e.g., pembrolizumab + lenvatinib) per treating physician Assignment is open-label, non-randomized; placement into an arm is decided before first dose by a central molecular \& PD-L1 board reviewing NGS/PCR and IHC results. No cross-over permitted.
| Arm | Type | Receives |
|---|---|---|
| BRAF V600E Mutation | Experimental | Drug: Dabrafenib, Drug: Trametinib, Drug: Lenvatinib, Drug: Anlotinib, Drug: Cabozantinib, Procedure: Conversion SurgeryDabrafenib 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. |
| RET Fusion PTC | Experimental | Drug: Selpercatinib, Drug: Pralsetinib, Drug: Lenvatinib, Drug: Anlotinib, Drug: Cabozantinib, Procedure: Conversion SurgerySelpercatinib 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. |
| RET Point-Mutation MTC | Experimental | Drug: Selpercatinib, Drug: Lenvatinib, Drug: Anlotinib, Drug: Cabozantinib, Procedure: Conversion SurgeryProspective 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. |
| NTRK Fusion | Experimental | Drug: Lenvatinib, Drug: Larotrectinib, Drug: Anlotinib, Drug: Cabozantinib, Procedure: Conversion SurgeryLarotrectinib 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. |
| TERT-Only (MKI) | Experimental | Drug: Lenvatinib, Drug: Anlotinib, Drug: Pembrolizumab, Drug: Sintilimab, Drug: Cabozantinib, Drug: Bemosuzumab, Procedure: Conversion SurgeryInvestigator-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. |
| Triple-Negative (driver-negative) - MKI | Experimental | Drug: Trametinib, Drug: Lenvatinib, Drug: Anlotinib, Drug: Pembrolizumab, Drug: Sintilimab, Drug: Cabozantinib, Drug: Bemosuzumab, Procedure: Conversion SurgerySame 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. |
| PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI | Experimental | Drug: Lenvatinib, Drug: Anlotinib, Drug: Pembrolizumab, Drug: Sintilimab, Drug: Cabozantinib, Drug: Bemosuzumab, Procedure: Conversion SurgeryCheckpoint 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years at enrollment.
- Histologically or cytologically confirmed thyroid carcinoma that meets ≥ 1 of the following:
- 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:
- ECOG Performance Status 0-2.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabrafenib150 mg orally twice daily; ≤4 × 28-day cycles | Drug | BRAF V600E Mutation |
| Trametinib2 mg orally once daily; same duration | Drug | BRAF V600E Mutation, Triple-Negative (driver-negative) - MKI |
| Selpercatinib160 mg orally twice daily; ≤4 cycles | Drug | RET Fusion PTC, RET Point-Mutation MTC |
| Pralsetinibretrospective, 400 mg orally once daily; ≤4 cycles | Drug | RET Fusion PTC |
| Lenvatinib24 mg orally once daily; ≤4 cycles | Drug | BRAF V600E Mutation, NTRK Fusion, PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, RET Fusion PTC, RET Point-Mutation MTC, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
| LarotrectinibLarotrectinib 100 mg orally twice daily, continuous 28-day cycles. | Drug | NTRK Fusion |
| Anlotinib12 mg orally once daily; 2 weeks on / 1 week off, ≤4 cycles (alternative) | Drug | BRAF V600E Mutation, NTRK Fusion, PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, RET Fusion PTC, RET Point-Mutation MTC, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
| Pembrolizumab200 mg IV infusion every 3 weeks; ≤4 cycles | Drug | PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
| Sintilimab200 mg IV infusion every 3 weeks; ≤4 cycles | Drug | PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
| CabozantinibCabozantinib 60 mg orally once daily, continuous 28-day cycles. | Drug | BRAF V600E Mutation, NTRK Fusion, PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, RET Fusion PTC, RET Point-Mutation MTC, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
| BemosuzumabChina PD-L1 antibody bemosuzumab 900 mg IV every 2 weeks (14-day cycle). | Drug | PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
| Conversion SurgeryConversion Surgery if resectable | Procedure or surgery | BRAF V600E Mutation, NTRK Fusion, PD-L1 ≥ 1 % / MKI-Refractory - Immunotherapy ± MKI, RET Fusion PTC, RET Point-Mutation MTC, TERT-Only (MKI), Triple-Negative (driver-negative) - MKI |
Primary outcome
Real-World Progression-Free Survival (rwPFS)
Time frame: Baseline to radiologic/clinical progression or death, whichever occurs first, up to 36 months
Time from Cycle 1 Day 1 to the earliest date of disease progression (RECIST/iRECIST) or all-cause death.
9 secondary outcomes
Real-World Objective Response Rate (rwORR)
Time frame: Baseline to first documented response, assessed every 8-12 weeks, up to 24 months
Pathologic Tumor Regression ≥ 50 %
Time frame: At surgery
R0/1 Resection Rate
Time frame: At surgery (≈ 1-5 months after first dose)
Conversion-to-Surgery Rate
Time frame: Up to 12 months from first dose
Overall Survival (OS)
Time frame: Baseline to death from any cause, censored at 36 months
Duration of Response (DoR)
Time frame: From first documented response until progression or death, up to 36 months
Incidence of Grade ≥ 3 Treatment-Related AEs
Time frame: Baseline to 30 days after last dose
Quality-of-Life Change (EORTC QLQ-THY34)
Time frame: Baseline, pre-surgery, and 6 months post-surgery
Thyroglobulin Reduction ≥ 90 %
Time frame: Pre-surgery (≈ 4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Undecided. De-identified datasets will be available 6 months after primary publication via institutional repository upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabrafenib, Trametinib and Selpercatinib in people with Thyroid Neoplasms, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Wang Professor, MD (+13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-World Progression-Free Survival (rwPFS) (time frame: Baseline to radiologic/clinical progression or death, whichever occurs first, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.