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Differentiated Thyroid CancerPhase 3NCT03048877

Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer

A Phase 3 study testing Apatinib Oral Tablet in people with Differentiated Thyroid Cancer, run by Peking Union Medical College Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and lenvatinib which have been approved by food and drug administration (FDA), could not be affordable for most of the Chinese patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Differentiated Thyroid Cancer
What is being tested?
Apatinib Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
2 sitesChina
Study dates
Dec 2016to 31 Dec 2023
Phase
Phase 3
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

  • Aged after 18 years (18 is included).
  • 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 12 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 Bequerel（GBq）[≥ 100 millicurie（mCi）]) and target lesion disease progression;
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  • Every two radioactive iodine treatment interval <12 months, doses ≥ 3.7 GBq [≥100mCi], 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);
  • Normal main organ function:
  • HB ≥ 90g / L;
  • ANC ≥1.5×109/L;
  • PLT ≥80×109/L;
  • BIL <1.5 × ULN;
  • ALT and AST <2.5 × ULN;
  • Cr≤1×ULN;
  • Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2.
  • An expected survival of ≥ 3 months.
  • Pregnancy test (serum) 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.
  • Good compliance is expected, according to the program requirements follow-up and recorded adverse reactions.

Who cannot join

  • Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma).
  • Received VEGFR inhibitor (such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.) treatment within 1 months.
  • 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 Class II; 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, nausea, vomiting, 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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  • Disposition evidence of thrombosis/bleeding in 2 month (despite severity), hemoptysis in 2 months (bright red blood, 1/2 teaspoon).
  • Arterial /venous thromboembolic events, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism in the past 12 months.
  • Factors that could received radiotherapy or major surgery for anti - thyroid cancer in the past 28 days.
  • Factors that could received surgery (allows the full-recovery wound) or active hemorrhage, ulceration, intestinal perforation or intestinal obstruction in the past 28 days.
  • Uncontrolled infection.
  • Pregnant or lactating women.
  • Disposition evidence of depressive disorder (HAMD score ≥17).
  • Other conditions regimented at investigators' discretion.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Nanjing PLA 81 Hospital

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Apatinib in Locally Advanced or Metastatic Radioactive Iodine-refractory Differentiated Thyroid Cancer

Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and lenvatinib which have been approved by food and drug administration (FDA), could not be affordable for most of the Chinese patients. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor effectively, which is a proven and effective drug in many solid tumors. A phase II study aims to assess the efficacy and safety of apatinib in RAIR-DTC ,which enrolled 20 patients and 10 of them had obtained a shout-term efficacy, demonstrating the peculiar potential in treatment of RAIR-DTC. In this study, the investigators aim to further explore the efficacy and safety of apatinib in RAIR-DTC.

Read the detailed description

Primary Outcome Measure: Progression free survival of apatinib in RAIR-DTC.

Secondary Outcome Measures: Disease control rate, objective response rate, duration of response, changes of Tg and TgAb level in serum, overall survival, side effects and quality of life.

Being tested
Apatinib Oral Tablet, Placebo Oral Tablet
Keywords
Radioactive iodine-refractory, differentiated thyroid cancer, Apatinib, anti-angiogenesis drugs

What participants receive

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

  • Apatinib Oral TabletDrug

    Apatinib Mesylate Tablets

  • Placebo Oral TabletDrug

    Placebo Oral Tablet

Study groups in NCT03048877
Study groupRoleWhat they receive
ApatinibExperimentalApatinib Mesylate Tablets
Receives: Drug: Apatinib Oral Tablet
PlaceboPlacebo comparatorPlacebo Tablets
Receives: Drug: Placebo Oral Tablet

What is being measured

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

  1. PFS

    Progression free survival

    Measured: 24 months

Secondary outcomes (6)

  1. DCR

    Disease control rate

    Measured: 24 months

  2. ORR

    Objective response rate

    Measured: 24 months

  3. DoR

    Duration of response

    Measured: 24 months

  4. Changing trend of Tg and TgAb level in serum

    Monitor the changes of Tg and TgAb level in serum regularly ( every 2~8 weeks, and addition examinations were needed if the participants' condition changed ) and draw the relevant changing curve to monitor the change of disease.

    Measured: 24 months

  5. OS

    Overall survival

    Measured: 24 months

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Record the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 24 months

Timeline

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

  1. First posted9 Feb 2017 (estimated)
  2. Study startDec 2016
  3. Primary completion25 Mar 2020
  4. Study completion31 Dec 2023 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03048877
Sponsor's protocol ID
PUMCH-NPLA81H-Ahead-T302
Status last verified
Apr 2023
First submitted
3 Feb 2017
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
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

  • Zhu Y, Liu K, Wang K, Peng L. Vascular Endothelial Growth Factor Receptor Inhibitors in Chinese Patients With Advanced Radioactive Iodine-Refractory Differentiated Thyroid Cancer: A Network Meta-Analysis and Cost-Effectiveness Analysis. Front Endocrinol (Lausanne). 2022 Jul 14;13:909333. doi: 10.3389/fendo.2022.909333. eCollection 2022.

    PubMed 35909569

  • Lin Y, Qin S, Li Z, Yang H, Fu W, Li S, Chen W, Gao Z, Miao W, Xu H, Zhang Q, Zhao X, Bao J, Li L, Ren Y, Lin C, Jing S, Ma Q, Liang J, Chen G, Zhang H, Zhang Y, Zhou X, Sang Y, Hou Z. Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer: The REALITY Randomized Clinical Trial. JAMA Oncol. 2022 Feb 1;8(2):242-250. doi: 10.1001/jamaoncol.2021.6268.

    PubMed 34913959

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apatinib Oral Tablet in people with Differentiated Thyroid Cancer, run by Peking Union Medical College Hospital at 2 sites 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 20 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

PFS (time frame: 24 months). 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 NCT03048877, 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 12 Apr 2023.

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