Study on the Treatment of Differentiated Thyroid Carcinoma with Anlotinib

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.

Study Overview

• Status: Active, not recruiting
• Conditions: DTC - Differentiated Thyroid Cancer
• Intervention / Treatment: Drug: Anlotinib hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib hydrochloride; 12 mg, 2 weeks on/ 1 week off, 21 days per cycle; treatment interruption or reduction (to 10 mg or 8 mg) was allowed	Drug: Anlotinib hydrochloride; If intolerance occurs, the dose can be downregulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in glucose metabolism	Evaluated by maximum standard uptake value (SUVmax)	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to response (TTR)	up to 24 months
PFS	up to 24 months

Collaborators and Investigators

• Sponsor: Yansong Lin

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): November 1, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Anlotinib
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: EXPLORE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No