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Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma

The Effectiveness and Safety of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma: a Phase 2 Trial.

NCT03167385•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with locally advanced or metastatic differentiated thyroid carcinoma.

Detailed Description

At present, multiple anti-angiogenesis drugs for thyroid cancer of clinical research are ongoing worldwide, and most of which achieved fairly good therapeutic effect. To date, sorafenib has been approved for the treatment of radioactive iodine refractory DTC. Apatinib is a highly selective VEGFR2 inhibitor that reduces the angiogenesis of tumor efficiently, and had been proven to be effective in many solid tumors. In this study, the investigators aim to further explore the efficacy and safety of apatinib in locally advanced or metastatic differentiated thyroid carcinoma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed consent.
•2. Histopathology confirmed locally advanced or metastatic differentiated thyroid carcinoma, with measurable lesions (RECIST 1.1).
•3. Age:18-75 years, ECOG（Eastern Cooperative Oncology Group） Score:0-2, Expected survival period ≥ 3 months.
•4. Patients with disease progression which was confirmed by imaging in 18 months, and meet any one of the following four:
•1. The tumor invades important organs, and cannot be resectted completely, the remnant thyroid tissue is extensive and not suitable for further iodine treatment.
•2. Lesions have no iodine affinity.
•3. The cumulative dose of RAI (radioactive iodine) ≥ 600mCi or 22GBq.
•4. Patients with disease progression confirmed by radiological examination within 18 months of last RAI.
•5. Patients general condition meeting the following:
•Haemoglobin (HBG) ≥ 90 g/L, neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 80×109/L, total bilirubin (TBIL)\< 1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5×ULN (ALT and AST \< 5×ULN if have liver metastasis), SCr (serum creatinine) \<1.5×ULN, left ventricular ejection fraction ≥ 50% of normal.
+2 more criteria

Exclusion Criteria

•1. Patients with past apatinib treatment or have received two or more small molecular TKI (Tyrosine Kinase Inhibitor) drugs.
•2. Patients accepted external beam radiation therapy or iodine - 131 therapy in recent three months, or patients plan to receive the other systemic anti-tumor treatment during the study.
•3. Patient with history of another malignant disease within past 5 years, cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor are spared.
•4. Patients without unrelieved toxicity reaction above CTCAE grade, neurotoxicity and hair loss due to oxaliplatin are spared.
•5. Preconditions that impair successful oral medication intake (such as inability to swallow, chronic diarrhea).
•6. Patients with pleural effusion or ascites that lead to respiratory syndrome (above CTCAE grade 2).
•7. Patients with severe systemic diseases that might impair cardiac function, et al.
•8. Patients accepted major surgery、incision biopsy or obvious traumatic injury in 28 days before the study.
•9. Patients with physical signs or medical history of bleeding.
•10. Patients with thromboembolism event in 6 months.
+6 more criteria

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

March 22, 2017

Primary Completion Date

January 31, 2019

Completion Date

December 31, 2020

Last Updated

May 30, 2017

Enrollment

ESTIMATED participants

Conditions

Differentiated Thyroid Carcinoma

Interventions

Apatinib Mesylate

DRUG

Contacts

Ming Gao, MD

CONTACT

862223340123 gaoming@tjmuch.com

Xiangqian Zheng, MD

CONTACT

862223340123 xiangqian_zheng@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma

Inclusion Criteria

Exclusion Criteria

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