DTC - Differentiated Thyroid CancerPhase 2NCT05007093
Study on the Treatment of Differentiated Thyroid Carcinoma with Anlotinib
A Phase 2 study testing Anlotinib hydrochloride in people with DTC - Differentiated Thyroid Cancer, run by Yansong Lin at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of anlotinib in patients with locally advanced or metastatic differentiated thyroid cancer resistant to iodine therapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- DTC - Differentiated Thyroid Cancer
- What is being tested?
- Anlotinib hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Jun 2025
- Phase
- Phase 2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- locally advanced or metastatic RAIR-DTC (papillary, follicular [including Hürthle cell], and poorly differentiated) progressed within 18 months after the last treatment according to the Response Evaluation Criteria in Solid Tumors, version 1.1
- Patients with RAIR-DTC should meet at least 1 of the following conditions: (a) the tumor invaded vital organs, cannot be completely removed nor suitable for further iodine treatment, or (b) lesions do not demonstrate iodine uptake on any radioactive iodine scan, or (c) received cumulative RAI activity ≥22.3 GBq (≥600 mCi), or (d) tumors retained iodine uptake but demonstrated radiological examination confirmed disease progression within 18 months after RAI treatment.
- at least one measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- life expectancy of at least 6 months
- adequate main organ function ((a) Hemoglobin (HBG) ≥ 90g/L, (b) neutrophil count (ANC) ≥ 1.5×109/L, (c) platelet count (PLT) ≥ 80×109/L, (d) total bilirubin < 1.5×ULN (upper limit of normal), (e) alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5×ULN, if accompanied by liver metastases, then ALT and AST ≤ 5 × ULN; (f) serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min; (g) left ventricular ejection fraction ≥ 50% of the normal level
- Negative pregnancy test (serum or urine) within 7 days prior to enrollment for women of childbearing potential (subjects should use appropriate contraception until 6 months after the last dose)
Who cannot join
- Patients who have received external radiotherapy or iodine-131 therapy in recent 3 months, or plan to receive other systemic anti-tumor therapy or anti-tumor therapy with traditional Chinese medicine during the study period.
- Patients with other malignant tumors within 5 years or currently. Except primary cervical cancer, non-melanoma skin cancer and superficial bladder tumor.
- The toxicity of CTCAE (4.0) above grade 1 was not alleviated, excluding patients with neurotoxicity (≤ grade 2) and alopecia caused by oxaliplatin.
- With factors affecting oral administration (such as swallow, chronic diarrhea, etc.).
- Patients with pleural effusion or ascites causing respiratory syndrome (CTCAE2 level above).
- Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks.
- Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study on Efficacy of Anlotinib Hydrochloride in the Treatment of Locally Advanced or Metastatic Differentiated Thyroid Cancer
The purpose of this study is to evaluate the efficacy of anlotinib in patients with locally advanced or metastatic differentiated thyroid cancer resistant to iodine therapy.
- Conditions
- DTC - Differentiated Thyroid Cancer
- Being tested
- Anlotinib hydrochloride
- Keywords
- Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
If intolerance occurs, the dose can be downregulated
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib hydrochloride | Experimental | 12 mg, 2 weeks on/ 1 week off, 21 days per cycle; treatment interruption or reduction (to 10 mg or 8 mg) was allowed Receives: Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in glucose metabolism
Evaluated by maximum standard uptake value (SUVmax)
Measured: up to 24 months
Secondary outcomes (2)
Time to response (TTR)
Measured: up to 24 months
PFS
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Dec 2020
- Primary completion1 Nov 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DTC - Differentiated Thyroid CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yansong Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yansong Lin, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007093
- Sponsor's protocol ID
- EXPLORE-001
- Status last verified
- Oct 2024
- First submitted
- 9 Aug 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun D, Zhang X, Jin X, Shi C, Sun Y, Zhang Y, Liang J, Lin Y. BRAFV600E mutation is associated with better prognoses in radioactive iodine refractory thyroid cancer patients treated with multi-kinase inhibitors: a retrospective analysis of registered clinical trials. Thyroid Res. 2025 Feb 10;18(1):5. doi: 10.1186/s13044-025-00223-0.
PubMed 39924483
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on Efficacy of Anlotinib Hydrochloride in the Treatment of Locally Advanced or Metastatic Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05007093
- Acronym / sponsor ID
- EXPLORE-001
- Conditions
- DTC - Differentiated Thyroid Cancer
- Keywords
- Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yansong LinUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Aug 2021 (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.
The purpose of this study is to evaluate the efficacy of anlotinib in patients with locally advanced or metastatic differentiated thyroid cancer resistant to iodine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib hydrochloride | Experimental | Drug: Anlotinib hydrochloride12 mg, 2 weeks on/ 1 week off, 21 days per cycle; treatment interruption or reduction (to 10 mg or 8 mg) was allowed |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- locally advanced or metastatic RAIR-DTC (papillary, follicular [including Hürthle cell], and poorly differentiated) progressed within 18 months after the last treatment according to the Response Evaluation Criteria in Solid Tumors, version 1.1
- Patients with RAIR-DTC should meet at least 1 of the following conditions: (a) the tumor invaded vital organs, cannot be completely removed nor suitable for further iodine treatment, or (b) lesions do not demonstrate iodine uptake on any radioactive iodine scan, or (c) received cumulative RAI activity ≥22.3 GBq (≥600 mCi), or (d) tumors retained iodine uptake but demonstrated radiological examination confirmed disease progression within 18 months after RAI treatment.
- at least one measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- life expectancy of at least 6 months
Key exclusion criteria (8 listed)
- Patients who have received external radiotherapy or iodine-131 therapy in recent 3 months, or plan to receive other systemic anti-tumor therapy or anti-tumor therapy with traditional Chinese medicine during the study period.
- Patients with other malignant tumors within 5 years or currently. Except primary cervical cancer, non-melanoma skin cancer and superficial bladder tumor.
- The toxicity of CTCAE (4.0) above grade 1 was not alleviated, excluding patients with neurotoxicity (≤ grade 2) and alopecia caused by oxaliplatin.
- With factors affecting oral administration (such as swallow, chronic diarrhea, etc.).
- Patients with pleural effusion or ascites causing respiratory syndrome (CTCAE2 level above).
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 |
|---|---|---|
| Anlotinib hydrochlorideIf intolerance occurs, the dose can be downregulated | Drug | Anlotinib hydrochloride |
Primary outcome
The changes in glucose metabolism
Time frame: up to 24 months
Evaluated by maximum standard uptake value (SUVmax)
2 secondary outcomes
Time to response (TTR)
Time frame: up to 24 months
PFS
Time frame: up to 24 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 7 Nov 2024.
- Derived from this study: PubMed 39924483Sun D, Zhang X, Jin X, Shi C, Sun Y, Zhang Y, Liang J, Lin Y. BRAFV600E mutation is associated with better prognoses in radioactive iodine refractory thyroid cancer patients treated with multi-kinase inhibitors: a retrospective analysis of registered clinical trials. Thyroid Res. 2025 Feb 10;18(1):5. doi: 10.1186/s13044-025-00223-0.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib hydrochloride in people with DTC - Differentiated Thyroid Cancer, run by Yansong Lin 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in glucose metabolism (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007093, which also lists 1 linked publication.
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 7 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.