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Locally Advanced or Metastatic Radioiodine-refractory Differentiated Thyroid CarcinomaNCT06062563

Study of Anlotinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer

A study testing Anlotinib Hydrochloride Capsule and Penpulimab in people with Locally Advanced or Metastatic Radioiodine-refractory Differentiated Thyroid Carcinoma, run by Peking Union Medical College Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to observe and explore the efficacy and safety of Anlotinib combined with penpulimab in the treatment of radioiodine refractory differentiated thyroid cancer with first-line resistance to angiogenesis inhibitors, and to summarize the treatment experience of population. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anlotinib Hydrochloride Capsule and Penpulimab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
11 Nov 2023to 20 Aug 2025
Phase
Interventional
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

  • Patients voluntarily joined the study, signed the informed consent;
  • Patients were pathologically confirmed as locally advanced or metastatic differentiated thyroid cancer (DTC), having at least one measurable lesion (Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
  • Patients≥18 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 6 months;
  • Possessing imaging or clinical evidence of disease progression within the first 18 months of enrollment;
  • Progression of at least one anti-vascular drug（no more than 2）；
  • Tg and structural imaging examinations were performed at least twice before enrollment；
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  • Meet any of the following while meeting the above 3 items:（1）Lesions were not iodine-avid；（2） The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months. （3） Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
  • Major organ functions meet the following criteria within 7 days prior to the treatment:
  • Hemoglobin (Hb) ≥90g/L;
  • Absolute Neutrophil Count (ANC) ≥1.5×109/L;
  • Platelet (PLT) ≥80×109/L；
  • Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
  • Alanine transferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST ≤5×ULN； (f)Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance rate (CCr) ≥60ml/min； (g) The left ventricular ejection fraction was at least 50% of the normal level.
  • Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

Who cannot join

  • Complicated diseases and history:
  • Histologic subtypes of thyroid cancer other than the differentiated type (e.g., medullary carcinoma, lymphoma, or sarcoma) could not be enrolled; Patients currently have or had other malignancies within 5years. Cured localized tumors could be enrolled（e.g., Skin basal cell carcinoma）
  • Subjects with any severe and/or uncontrolled heart disease, including:
  • According to the criteria of New York Heart Association (NYHA) grade II or above cardiac insufficiency or echocardiography: LVEF (left ventricular ejection fraction) <50%;
  • Unstable angina
  • A myocardial infarction had occurred within 1 year before the beginning of the treatment
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  • Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention
  • QTc ≥450ms (male), QTc ≥470ms (female) (classified by New York heart association, NYHA);
  • Other anti-tumor treatment (including but not limited to chemotherapy, radiotherapy, etc.). were received within 28 days before the beginning of the treatment; TSH suppression therapy was excluded;
  • Patients who have previously used immune checkpoint inhibitors (including but not limited to nivolumab, pembrolizumab, toripalimab, sintilimab, etc.);
  • 5) Patients with hypertension that was not falling to the normal range with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) were allowed to use antihypertensive treatment to achieve these parameters. Hypertensive crisis or hypertensive encephalopathy.
  • 6) Multiple factors affect the absorption of oral drugs. 7）Patients at risk for gastrointestinal bleeding were not eligible, including the following: (1) patients with active peptic ulcer lesions and fecal occult blood (++); (2) patients with a history of melena and hematemesis within 3 months; 8). Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection); 9) Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • YansongLin

    Beijing, Beijing Municipality, 100007

    Yansong Lin, PhD, 13671116837, linys@pumch.cn

Other trials in China

About this study

Official title: An Exploratory Study to Evaluate the Efficacy of Anlotinib Hydrochloride Combined With Penpulimab in the Treatment of Radioiodine Refractory Differentiated Thyroid Cancer With First-line Resistance to Angiogenesis Inhibitors

This study aims to observe and explore the efficacy and safety of Anlotinib combined with penpulimab in the treatment of radioiodine refractory differentiated thyroid cancer with first-line resistance to angiogenesis inhibitors, and to summarize the treatment experience of population.

Being tested
Anlotinib Hydrochloride Capsule and Penpulimab

What participants receive

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

  • Anlotinib Hydrochloride Capsule and PenpulimabDrug

    Also called Anlotinib Hydrochloride Capsule, Penpulimab

    Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously.

    Penpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC.

Study groups in NCT06062563
Study groupRoleWhat they receive
Anlotinib+ penpulimabExperimentalAnlotinib：12 mg once daily for 2 weeks, followed by a rest of 1 week (21-day cycle)； Penpulimab：200mg Q3 W
Receives: Drug: Anlotinib Hydrochloride Capsule and Penpulimab

What is being measured

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

  1. Overall Response Rate (ORR)

    The proportion of subjects who achieves a best overall response of CR(Complete Response) or PR(Partial response).

    Measured: Baseline up to 2 years.

  2. changes in Tg level

    The percentage of decrease in serum Tg from baseline;

    Measured: Baseline up to 2 years.

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    From the first dose of Anlotinib to the date of objective disease progression or death, whichever occurs first

    Measured: Baseline up to 2 years.

  2. Disease-control Rate（DCR）

    The proportion of subjects response of CR, PR, or SD(Stable disease) (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks).

    Measured: Baseline up to 2 years.

  3. Duration of Response（DOR）

    From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.

    Measured: Baseline up to 2 years.

  4. Overall Survival（OS）

    From randomization to the time of death from any cause.

    Measured: Baseline up to 2 years.

  5. Time to response(TTR)

    From randomization to the time of response from any cause.

    Measured: Baseline up to 2 years.

Timeline

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

  1. First posted2 Oct 2023
  2. Study start11 Nov 2023 (estimated)
  3. Primary completion20 Dec 2024 (estimated)
  4. Study completion20 Aug 2025 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06062563
Sponsor's protocol ID
T004
Status last verified
Sep 2023
First submitted
25 Sep 2023
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Anlotinib Hydrochloride Capsule and Penpulimab in people with Locally Advanced or Metastatic Radioiodine-refractory Differentiated Thyroid Carcinoma, 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 14 inclusion and 12 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 2 Oct 2023. 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Baseline up to 2 years.). 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 NCT06062563.

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 2 Oct 2023.

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