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Medullary Thyroid Cancer (MTC)NCT07048964

A Prospective Cohort Study of Pralsetinib or Anlotinib in the Treatment of Locally Advanced and/or Metastatic Medullary Thyroid Carcinoma With RET Gene Mutations

An observational study of Medullary Thyroid Cancer (MTC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This trial is a prospective, observational Phase II clinical study. For patients with locally advanced and/or metastatic medullary thyroid carcinoma with RET gene mutations who require systemic treatment, they are randomly assigned to either the Pralsetinib or Anlotinib observation cohort based on their clinical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Medullary Thyroid Cancer (MTC)
How many people
40 participants
Where
No sites listed yet
Study dates
1 Aug 2025to 28 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients with RET gene mutation-related locally advanced or metastatic medullary thyroid carcinoma (MTC) who require systemic treatment.

Who may be able to join

  • Age ≥18 years.
  • Pathologically confirmed medullary thyroid carcinoma (MTC).
  • Patients with locally advanced or metastatic MTC who require systemic treatment.
  • Disease progression within 14 months before the screening visit.
  • Presence of RET gene mutations based on tumor tissue and/or blood evaluations conducted by the study center.
  • No prior treatment with pralsetinib and/or anlotinib and/or cabozantinib and/or vandetanib.
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
  • Expected survival time ≥ 3 months
  • Signed informed consent to participate in this study.

Who cannot join

  • The patient meets any of the following criteria within 14 days before the first administration of the study drug:
  • Platelet count < 75 × 10^9/L.
  • Absolute neutrophil count (ANC) < 1.0 × 10^9/L.
  • Hemoglobin < 9.0 g/dL, with the possibility of elevating hemoglobin to 9.0 g/dL or higher through red blood cell transfusion and erythropoietin use, provided such treatment is completed at least 2 weeks before the first administration of the study drug.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) without liver metastases; > 5 × ULN with liver metastases.
  • Total bilirubin > 1.5 × ULN, > 3 × ULN with liver metastases; in the case of Gilbert's syndrome, total bilirubin > 3 × ULN and direct bilirubin > 1.5 × ULN.
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  • Estimated (Cockcroft-Gault formula) or measured creatinine clearance < 60 mL/min.
  • The patient's QTcF > 470 msec. The patient has a history of long QT syndrome or torsades de pointes (TdP). The patient has a family history of long QT syndrome.
  • The patient has clinically significant, uncontrolled cardiovascular diseases, including congestive heart failure classified as New York Heart Association (NYHA) Class III or IV; myocardial infarction or unstable angina within 6 months; uncontrolled hypertension; or clinically significant uncontrolled arrhythmias, including bradyarrhythmias that may lead to QT prolongation (e.g., second-degree atrioventricular block type II or third-degree atrioventricular block).
  • The patient has metastatic central nervous system (CNS) tumors or primary CNS tumors with progressive neurological symptoms or requiring an increased dose of corticosteroids to control CNS disease. If corticosteroid treatment is needed for CNS disease, the dosing must be stable within the two weeks prior to C1D1.
  • The patient has symptomatic interstitial lung disease or interstitial pneumonia, including radiation pneumonitis (i.e., affecting daily activities or requiring therapeutic intervention).
  • The patient has received anti-tumor therapy within 14 days or five half-lives of the study drug prior to the first administration.
  • The patient has received granulocyte colony-stimulating factor (G-CSF) support therapy within 14 days prior to the first administration of the study drug.
  • The patient has undergone major surgery (excluding central venous catheterization, tumor biopsy, and gastrostomy tube insertion) within 14 days before the first administration of the study drug.
  • The patient has been diagnosed with or requires treatment for another primary malignancy within the past 3 years, except for completely resected basal cell and squamous cell carcinoma of the skin, localized prostate cancer after curative treatment, and any in situ carcinoma that has been fully resected.
  • The patient is unwilling or unable to comply with scheduled visits, dosing plan, laboratory tests, or other study procedures and restrictions.
  • Non-menopausal or non-surgically sterilized female subjects are unwilling to use abstinence or highly effective contraception during the study drug administration and for at least 30 days after the last administration of the study drug; non-sterilized male subjects are unwilling to use abstinence or highly effective contraception during the study drug administration and for at least 90 days after the last administration of the study drug.
  • Female patients who are currently breastfeeding.
  • In the investigator's judgment, the patient has previous or current clinically significant conditions, medical history, surgical history, physical examination findings, or laboratory abnormalities that might affect patient safety, alter the absorption, distribution, metabolism, or excretion of the study drug, or interfere with the evaluation of study results.

About this study

This trial is a prospective, observational Phase II clinical study. For patients with locally advanced and/or metastatic medullary thyroid carcinoma with RET gene mutations who require systemic treatment, they are randomly assigned to either the Pralsetinib or Anlotinib observation cohort based on their clinical treatment choices. The treatment continues until disease progression or the occurrence of intolerable adverse reactions. At the same time, the correlation between the efficacy and safety of the drugs and the RET gene mutation subtypes is analyzed, and the resistance mechanisms of Anlotinib and Pralsetinib are preliminarily explored to provide more evidence for the clinical treatment of patients with locally advanced or metastatic MTC in China.

Medical subject headings
Carcinoma, Medullary

What participants receive

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

Study groups in NCT07048964
Study groupRoleWhat they receive
Drug: PralsetinibNot described
Drug: AnlotinibNot described

What is being measured

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

  1. To evaluate the objective response rate (ORR) of Pralsetinib or Anlotinib in patients with RET gene mutation-related locally advanced or metastatic medullary thyroid carcinoma (MTC) who require systemic treatment

    Defined as complete response (CR) or partial response (PR) according to RECIST v1.1

    Measured: 24 months

Secondary outcomes (6)

  1. Progression-free survival (PFS) as assessed by Investigator

    Measured: 24 months

  2. Duration of Response (DOR)

    Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first

    Measured: 24 months

  3. Disease control rate (DCR)

    Measured: 24 months

  4. Changes in blood calcitonin (CT) and carcinoembryonic antigen (CEA)

    Measured: 24 months

  5. Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0) of Pralsetinib or Anlotinib

    Seriousness and attribution to the study medications of AEs and any laboratory abnormalities

    Measured: 24 months

  6. Conversion rate of initially inoperable locally advanced medullary thyroid carcinoma (MTC) patients to surgically resectable status after treatment with pralsetinib or anlotinib

    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 posted3 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07048964
Sponsor's protocol ID
22/284-3486
Status last verified
Jun 2025
First submitted
23 May 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Medullary Thyroid Cancer (MTC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

To evaluate the objective response rate (ORR) of Pralsetinib or Anlotinib in patients with RET gene mutation-related locally advanced or metastatic medullary thyroid carcinoma (MTC) who require systemic treatment (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 NCT07048964.

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 3 Jul 2025.

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