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Thyroid CancerPhase 2NCT04309136

Anlotinib Neoadjuvant Treatment in Locally Advanced Thyroid Cancer

A Phase 2 study testing Anlotinib, surgery and core needle biopsy in people with Thyroid Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the efficacy and safety of Anlotinib in patients of locally advanced thyroid cancer in the neoadjuvant setting. Read more about this study

Who is it for?
Ages 14 to 80 years
Conditions the study is for
Thyroid Cancer
What is being tested?
Anlotinib, surgery and core needle biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteChina
Study dates
1 Jun 2019to 1 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 14 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The patient volunteered to participate in the study and signed an informed consent form;
  • Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis;
  • Preoperative assessment of invasion or adhesion of at least one of the following structures / organs, including: trachea, esophagus, common carotid artery, larynx, anterior vertebral fascia, brachial plexus, intended for surgical treatment;
  • Have at least one measurable lesion (RECIST 1.1);
  • Age 14-80 years, Eastern Cooperative Oncology Group (ECOG) score 0-1;
  • The main organ functions meet the following criteria within 7 days before treatment:
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  • Standard blood test (without blood transfusion within 14 days):Hemoglobin (HB) ≥90g / L;Absolute neutrophil value (ANC) ≥ 1.5 × 109 / L;Platelet (PLT) ≥80 × 109 / L
  • Biochemical inspection must meet the following standards:Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN, if with liver metastases, ALT and AST ≤ 5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60ml / min;
  • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).
  • Women of childbearing age should agree to use contraceptives during the study and within 6 months after the study; negative serum or urine pregnancy tests within 7 days before study enrollment; men should agree to use contraception during the study period and within 6 months after the end of the study period.

Who cannot join

  • Previously used anlotinib or similar VEGFR-TKI small molecule drugs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib and etc.
  • Received external radiation therapy or iodine-131 therapy within the past 3 months; or planned systemic anti-tumor therapy during this study;
  • Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.);
  • With other uncontrolled / under treatment malignancies;
  • Those who have multiple factors (such as inability to swallow) that affect oral medication;
  • With pleural effusion or ascites, causing respiratory syndrome (≥CTC AE level 2 dyspnea [level 2 dyspnea refers to shortness of breath when a small amount of activity; affecting instrumental daily activities]);
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  • Patients with any severe and / or uncontrolled illness, including:
  • Patients whose blood pressure is still unsatisfactory with a blood pressure medication (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);
  • Patients with myocardial ischemia or myocardial infarction of grade I or higher and congestive heart failure of grade 2 or higher (New York Heart Association (NYHA) classification);
  • Sinus bradycardia; or atrioventricular block of more than two degrees, or sinus arrest (except for pacemakers); arrhythmia (including QTC ≥480ms); need to be used together to extend QTc interval drugs, including those for antiarrhythmic treatment;
  • Active or uncontrolled severe infection (≥CTC AE level 2 infection);
  • Patients with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis;
  • Renal failure requires hemodialysis or peritoneal dialysis;
  • Have a history of immunodeficiency, including those who are HIV positive or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
  • Poor blood glucose control in diabetic patients (fasting blood glucose (FBG)> 10mmol / L);
  • Urine routine indicates urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g.
  • received major surgical treatment, incisional biopsy or obvious traumatic injury within 28 days before enrollment;
  • Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding;
  • Patients with any signs or history of bleeding regardless of severity; patients with any bleeding or bleeding event ≥ CTCAE level 3 within 4 weeks prior to grouping with unhealed wounds, ulcers or fractures
  • Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism within 6 months;
  • History of aneurysm;
  • Those with a history of epilepsy or neurological disorders with ataxia in need of treatment;
  • People with a history of psychotropic substance abuse who are unable to quit or have mental disorders;
  • Those with a history of peripheral nervous system disease and muscle strength below 3;
  • Those who have participated in other clinical trials of anti-tumor drugs within four weeks or are conducting other clinical trials;
  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: The Efficacy and Safety of Anlotinib in Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: a Single-arm Phase II Clinical Trial

To determine the efficacy and safety of Anlotinib in patients of locally advanced thyroid cancer in the neoadjuvant setting.

Conditions
Thyroid Cancer
Being tested
Anlotinib, surgery, core needle biopsy
Keywords
thyroid cancer, locally advanced, neoadjuvant, Anlotinib
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    All patients will receive Anlotinib for at least two cycles of neoadjuvant treatment

  • surgeryProcedure or surgery

    Perform surgery if operable after neoadjuvant therapy

  • core needle biopsyProcedure or surgery

    Perform core needle biopsy if inoperable after neoadjuvant therapy

Study groups in NCT04309136
Study groupRoleWhat they receive
Neoadjuvant AnlotinibExperimentalNot described
Receives: Drug: Anlotinib; Procedure: surgery; Procedure: core needle biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    ORR

    Measured: at the time point of 18 weeks

Secondary outcomes (4)

  1. R0/1 resection rate

    R0/1 resection rate if operable

    Measured: at the time of surgery

  2. Disease control rate

    DCR

    Measured: at the time point of 18 weeks

  3. Overall survival

    OS

    Measured: up to 3 years

  4. Adverse Events

    AEs

    Measured: from the first drug administration to within 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start1 Jun 2019
  3. Primary completion1 Feb 2021
  4. Study completion1 Jun 2022 (estimated)

Resources

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309136
Sponsor's protocol ID
AHNATHY
Status last verified
Mar 2021
First submitted
12 Mar 2020
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang NS, Wei WJ, Xiang J, Chen JY, Guan Q, Lu ZW, Ma B, Sun GH, Wang YL, Ji QH, Wang Y. The Efficacy and Safety of Anlotinib in Neoadjuvant Treatment of Locally Advanced Thyroid Cancer: A Single-Arm Phase II Clinical Trial. Thyroid. 2021 Dec;31(12):1808-1813. doi: 10.1089/thy.2021.0307. Epub 2021 Nov 29.

    PubMed 34610756

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib, surgery and core needle biopsy in people with Thyroid Cancer, run by Fudan 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 10 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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?

Results are not available in the source record.

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?

Objective response rate (time frame: at the time point of 18 weeks). 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 NCT04309136, 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 1 Apr 2021.

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