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Thyroid CancerPhase 2NCT02731352

Study of Apatinib in Patients With Differentiated Thyroid Cancer

A Phase 2 study testing Apatinib in people with Thyroid Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
11 Mar 2016to 28 Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
  • Disease progression within 14 months before inclusion;
  • 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;
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  • Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi)
  • main organs function is normal;
  • Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2;
  • An expected survival of ≥ 3 months;
  • 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;
  • Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

Who cannot join

  • Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma);
  • Received VEGFR inhibitor treatment within 1 month;
  • 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;
  • Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  • 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;
  • Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
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  • Received anti-thyroid cancer chemotherapy treatment (allows the use of low-dose chemotherapy with radiation sensitizer) or thalidomide(or derivative) therapy;
  • Pregnant or lactating women;
  • Other conditions regimented at investigators' discretion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, 100730

Other trials in China

About this study

Official title: Study of Apatinib in Patients With Local Advanced/Metastatic Iodine-131（131I）-Refractory/Resistant Differentiated Thyroid Cancer

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
Being tested
Apatinib
Keywords
apatinib, Iodine-131, Differentiated Thyroid Cancer, refractory, resistant
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called Apatinib 750mg

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

  • ApatinibDrug

    Also called Apatinib 500mg

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

Study groups in NCT02731352
Study groupRoleWhat they receive
iodine-131 Refractory/Resistant Differentiated Thyroid CancerExperimentaliodine-131 (131I) -Refractory/Resistant Differentiated Thyroid Cancer
Receives: Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (DCR)

    Disease control rate

    Measured: An expected average of 8 weeks

  2. Objective response rate (ORR)

    Objective response rate

    Measured: An expected average of 8 weeks

Secondary outcomes (2)

  1. Progression free survival (PFS)

    progression free survival

    Measured: Up to approximately 43 months

  2. Overall survival (OS)

    overall survival

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2016 (estimated)
  2. Study start11 Mar 2016
  3. Primary completion27 Feb 2020
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02731352
Sponsor's protocol ID
Ahead-T301
Status last verified
Aug 2021
First submitted
7 Mar 2016
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39924483

  • 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.

    PubMed 33769497

  • 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.

    PubMed 30053006

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Thyroid Cancer, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) (time frame: An expected average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02731352, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.

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