Study on the Treatment of Differentiated Thyroid Carcinoma with Anlotinib

NCT05007093 | Active Not Recruiting Phase 2

• 1 other identifier: EXPLORE-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

DTC - Differentiated Thyroid Cancer

Keywords

Anlotinib

Outcome Measures

Primary Outcomes (1)

• The changes in glucose metabolism

  Evaluated by maximum standard uptake value (SUVmax)

  up to 24 months

Secondary Outcomes (2)

• Time to response (TTR)

  up to 24 months

• PFS

  up to 24 months

Study Arms (1)

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

Drug: Anlotinib hydrochloride

Interventions

Anlotinib hydrochloride DRUG

If intolerance occurs, the dose can be downregulated

Anlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yansong Lin: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 39924483 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. M.D.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: December 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: June 30, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)