Clinical trial · Interventional
Study of Neoadjuvant Regimen for Radioactive Iodine Treatment of Metastatic and Advanced Differentiated Thyroid Cancers
Evaluating the Safety and Efficacy of Radioactive Iodine (RAI) Treatment of Metastatic and Advanced Differentiated Thyroid Cancers by Pretreatment With Apatinib for the Neoadjuvant Regimen
NCT04180007CI-TRIAL-00041968APT-01unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
| Thyroid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant arm
- description
- Patients receive Apatinib orally qd up to 12 wk.
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 4 month
- description
- Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria (RECIST v1.1 criteria) in Solid Tumors.
Secondary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- Time interval from start to 3 months after completion of the therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient volunteers and signs an informed consent form. 2. age ≥18 and \<99 years old; 3. Diagnosed as differentiated thyroid cancer (DTC) by histopathology; 4. surgically inoperable and/or recurrent/metastatic differentiated thyroid cancers; 5. 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. 6. There must be at least one measurable lesion (according to RECIST v1.1); 7. Physical condition ECOG PS: 0-2; 8. Expected survival time ≥ 3 months; 9. 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 10. Well controlled blood pressure prior to study entry. 11. At least one or more hypermetabolic lesions other than the neck on 18F-FDG PET scans Exclusion Criteria: 1. Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid; 2. Previous treatment with chemotherapy for anti-thyroid cancer (allowing low-dose chemotherapy for radiation sensitization) or treatment with thalidomide or its derivatives; 3. Previous treatment with VEGFR-TKI small molecule drugs within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.; 4. Major surgery within 4 weeks prior to enrollment, or received anti-thyroid cancer radiotherapy; 5. 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; 6. Severe infection requires intravenous antibiotic, antifungal or antiviral treatment; 7. Active hemoptysis (bright red blood of at least one-half teaspoon) in the 28 days prior to study entry; 8. Suffering from mental illness, poor compliance; 9. Pregnant women will be ineligible; breast feeding should be discontinued if the mother is treated with Apatinib; 10. Embolization and bleeding occurred within 4 weeks before enrollment; 11. Patient with a risk of gastrointestinal bleeding; abnormal coagulation function (INR \> 1.5, APTT \> 1.5 × ULN); 12. Arteriovenous thrombosis such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism within 12 months prior to screening; 13. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction)
References
Publications (1)
- DERIVEDShi 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