Study of Apatinib in Patients With Differentiated Thyroid Cancer

NCT ID: NCT02731352

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-11
• Study Completion Date: 2021-02-28

Brief Summary

The purpose of this study is to assess the efficacy and safety of apatinib in locally advanced/metastatic radioactive iodine-refractory/resistant differentiated thyroid cancer

Conditions

Thyroid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iodine-131 Refractory/Resistant Differentiated Thyroid Cancer

iodine-131 (131I) -Refractory/Resistant Differentiated Thyroid Cancer

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib Mesylate Tablets 750 mg q.d p.o. in 1-10 cases of differentiated thyroid cancer subjects.

Apatinib

Intervention Type: DRUG

Apatinib Mesylate Tablets 500 mg q.d. p.o. in 11-20 cases of differentiated thyroid cancer subjects.

Interventions

Apatinib

Apatinib Mesylate Tablets 750 mg q.d p.o. in 1-10 cases of differentiated thyroid cancer subjects.

Intervention Type: DRUG

Apatinib

Apatinib Mesylate Tablets 500 mg q.d. p.o. in 11-20 cases of differentiated thyroid cancer subjects.

Intervention Type: DRUG

Other Intervention Names

Apatinib 750mg; Apatinib 500mg

Eligibility Criteria

Inclusion Criteria

1. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1);

2. Disease progression within 14 months before inclusion;

3. Subjects must be 131I-refractory / resistant as defined by at least one of the following;

• Lesions that do not demonstrate iodine uptake on any radioiodine scan
• Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Becquerel (GBq) [≥ 100 millicurie (mCi) ]) and target lesion disease progression
• Every two radioactive iodine treatment interval <12 months, doses ≥ 3.7 GBq [≥100 mCi], disease progress more than 12 months after at least once iodine therapy;
• Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi)

4. main organs function is normal;

5. Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2;

6. An expected survival of ≥ 3 months;

7. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug;

8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

Exclusion Criteria

1. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma);

2. Received VEGFR inhibitor treatment within 1 month;

3. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; II-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac dysfunction;

4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);

5. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 3 months;

6. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;

7. Received anti-thyroid cancer chemotherapy treatment (allows the use of low-dose chemotherapy with radiation sensitizer) or thalidomide(or derivative) therapy;

8. Pregnant or lactating women;

9. Other conditions regimented at investigators' discretion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yansong Lin

Prof. M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39924483 (View on PubMed)

Lin YS, Zhang X, Wang C, Liu YQ, Guan WM, Liang J. Long-Term Results of a Phase II Trial of Apatinib for Progressive Radioiodine Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3027-e3036. doi: 10.1210/clinem/dgab196.

Reference Type: DERIVED

PMID: 33769497 (View on PubMed)

Zhang X, Wang C, Lin Y. Pilot Dose Comparison of Apatinib in Chinese Patients With Progressive Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2018 Oct 1;103(10):3640-3646. doi: 10.1210/jc.2018-00381.

Reference Type: DERIVED

PMID: 30053006 (View on PubMed)

Other Identifiers

Ahead-T301

Identifier Type: -

Identifier Source: org_study_id