Study of Neoadjuvant Regimen for Radioactive Iodine Treatment of Metastatic and Advanced Differentiated Thyroid Cancers

NCT04180007 | Unknown Phase 2

• 1 other identifier: wangfeng-Apatinib-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine Safety and Efficacy of Radioactive Iodine (RAI) Treatment of Metastatic and Advanced Differentiated Thyroid Cancers by Pretreatment With Apatinib for the Neoadjuvant Regimen

Conditions

Thyroid; Metastasis; Apatinib

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria (RECIST v1.1 criteria) in Solid Tumors.

  4 month

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Time interval from start to 3 months after completion of the therapy

• Change From Baseline in Serum Thyroglobulin Levels After Treatment With RAI (131I)

  Baseline, 4 weeks, 12 weeks and 1 month after RAI

Study Arms (1)

Neoadjuvant arm

EXPERIMENTAL

Patients receive Apatinib orally qd up to 12 wk.

Drug: Apatinib

Interventions

Apatinib DRUG

500 mg Apatinib given orally once a day for 12 wk prior to RAI (131I) treatment.

Neoadjuvant arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteers and signs an informed consent form.
• age ≥18 and \<99 years old;
• Diagnosed as differentiated thyroid cancer (DTC) by histopathology;
• surgically inoperable and/or recurrent/metastatic differentiated thyroid cancers;
• Did not receive molecular targeting treatment; Prior RAI therapy is allowed if \> 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim.
• There must be at least one measurable lesion (according to RECIST v1.1);
• Physical condition ECOG PS: 0-2;
• Expected survival time ≥ 3 months;
• Laboratory tests meet the following criteria: Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L; Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN\*2.5
• Well controlled blood pressure prior to study entry.
• At least one or more hypermetabolic lesions other than the neck on 18F-FDG PET scans

You may not qualify if:

• Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid;
• Previous treatment with chemotherapy for anti-thyroid cancer (allowing low-dose chemotherapy for radiation sensitization) or treatment with thalidomide or its derivatives;
• Previous treatment with VEGFR-TKI small molecule drugs within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.;
• Major surgery within 4 weeks prior to enrollment, or received anti-thyroid cancer radiotherapy;
• Severe cardiovascular disease, including hypertension (BP≥140/90mmHg) uncontrolled by medical treatment, unstable angina, history of myocardial infarction, congestive heart failure\>NYHA II, Marked baseline prolongation of QT/corrected QT (QTc) interval;
• Severe infection requires intravenous antibiotic, antifungal or antiviral treatment;
• Active hemoptysis (bright red blood of at least one-half teaspoon) in the 28 days prior to study entry;
• Suffering from mental illness, poor compliance;
• Pregnant women will be ineligible; breast feeding should be discontinued if the mother is treated with Apatinib;
• Embolization and bleeding occurred within 4 weeks before enrollment;
• Patient with a risk of gastrointestinal bleeding; abnormal coagulation function (INR \> 1.5, APTT \> 1.5 × ULN);
• Arteriovenous thrombosis such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism within 12 months prior to screening;
• A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jingsu, 210006, China

RECRUITING

Related Publications (1)

• Shi L, You Q, Wang J, Wang H, Li S, Tian R, Yao X, Wu W, Zhang L, Wang F, Lin Y, Li S. Antitumour effects of apatinib in progressive, metastatic differentiated thyroid cancer (DTC). Endocrine. 2022 Oct;78(1):68-76. doi: 10.1007/s12020-022-03113-9. Epub 2022 Jun 29.

  PMID: 35767182 DERIVED

MeSH Terms

Conditions

Thyroid Diseases; Neoplasm Metastasis

Interventions

apatinib

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Wang, PhD MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang, PhD MD

CONTACT

+8618951670836; fengwangcn@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 27, 2019
• Study Start: April 10, 2019
• Primary Completion: April 10, 2020
• Study Completion: May 30, 2020
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

CN (1)