NCT04309136

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

March 12, 2020

Last Update Submit

March 30, 2021

Conditions

Thyroid Cancer

Keywords

thyroid cancerlocally advancedneoadjuvantAnlotinib

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    ORR

    at the time point of 18 weeks

Secondary Outcomes (4)

  • R0/1 resection rate

    at the time of surgery

  • Disease control rate

    at the time point of 18 weeks

  • Overall survival

    up to 3 years

  • Adverse Events

    from the first drug administration to within 90 days after surgery

Study Arms (1)

Neoadjuvant Anlotinib

EXPERIMENTAL
Drug: AnlotinibProcedure: surgeryProcedure: core needle biopsy

Interventions

AnlotinibDRUG

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

Neoadjuvant Anlotinib
surgeryPROCEDURE

Perform surgery if operable after neoadjuvant therapy

Neoadjuvant Anlotinib
core needle biopsyPROCEDURE

Perform core needle biopsy if inoperable after neoadjuvant therapy

Neoadjuvant Anlotinib

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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 \[level 2 dyspnea refers to shortness of breath when a small amount of activity; affecting instrumental daily activities\]);
  • 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);
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 34610756DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

anlotinibSurgical Procedures, OperativeBiopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalPuncturesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

June 1, 2019

Primary Completion

February 1, 2021

Study Completion

June 1, 2022

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)