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Thyroid CancerPhase 2NCT04521348

Multiple Target Kinase Inhibitor and Anti-Programmed Death-1 Antibody in Patients With Advanced Thyroid Cancer

A Phase 2 study testing multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody in people with Thyroid Cancer, run by Fudan University 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 study is being conducted to evaluate the safety and efficacy of Multiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody in subjects with advanced 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?
multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteChina
Study dates
30 Dec 2019to 31 Dec 2024
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

  • Patients volunteered to participate in this study and signed informed consent;
  • Age: ≥ 18 years old, male or female;
  • Advanced thyroid cancer patients couldn't be treated by local treatment such as surgery or microwave ablation, and are confirmed by histopathology or cytology to be one of the following three types of thyroid cancer:
  • Local advanced or metastatic differentiated thyroid cancer, including papillary thyroid carcinoma (including follicular subtypes and poorly differentiated subtypes) and thyroid follicular carcinoma (including Hürthle cell subtypes, etc.).
  • Local advanced or metastatic medullary thyroid carcinoma.
  • Anaplastic thyroid cancer.
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  • Differentiated thyroid cancer patients need to meet the definition of radioiodine refractory or is not suitable for 131I treatment. The definition of radioactive iodine refractory is as follows (meet one of the following conditions):
  • At least one measurable lesion completely loses iodine uptake during radioiodine therapy;
  • Although the lesion has iodine-receiving ability, at least one measurable lesion can still achieve progressive disease within 12 months after iodine131 treatment.
  • has received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi), and the final radioactive iodine therapy was within six months before enrollment;
  • If the subject is a patient with differentiated thyroid cancer, the TSH level should be at the inhibition level (<0.5 micro unit/L) from the screening period.
  • At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
  • Perfomance Status: 0~2;
  • Estimated survival time ≥ 12 weeks;
  • The main organs function are normal, and meet the following requirements (within 7 days before the start of study treatment):
  • Blood routine examination(no blood transfusion within 14 days before screening, no granulocyte colony stimulating factor (G-CSF), no medication corrected):1) Hemoglobin (HB)≥ 90g / L;2) Neutrophil count (ANC) ≥ 1.5 × 109 / L;3) platelets (PLT) ≥ 80 × 109 / L;
  • Blood biochemical tests are subject to the following criteria (no albumin is delivered 14 days prior to screening):1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN;3) Serum creatinine (Cr) ≤ 1 × ULN or endogenous creatinine clearance > 50ml / min (Cockcroft-Gault formula);
  • International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the range of normal controls ≤ 6 seconds;
  • Urine protein <2+ (if urine protein ≥ 2+, 24-hour urine protein can be quantified, 24-hour urine protein quantitation <1.0g can be included);
  • Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and volunteer to use appropriate methods during the observation period and within 8 weeks after the last study drug administration; for men, sterilization surgery should be performed, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug;
  • Patients voluntarily undergo tumor biopsy at the time of enrollment and out of the group.
  • Patient who are expected to have good compliance and can accept follow-up visit for the efficacy and adverse reactions according to the program requirements.

Who cannot join

  • Have other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled.
  • Other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, etc.) were used within 28 days prior to the first use of the study drug. Except for thyroid stimulating hormone (TSH) inhibition therapy.
  • Patients who have previously been treated with immunological checkpoint inhibitors (including but not limited to Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, etc.).
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as:
  • According to the New York Heart Association (NYHA) standard, level II or higher cardiac dysfunction or echocardiography: left ventricular ejection fraction<50%;
  • unstable angina;
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  • Myocardial infarction occurred within 1 year before the start of treatment;
  • Clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention;
  • corrected QT interval(QTc) > 450ms (male); QTc > 470ms (female) (Calculation of QTc interval with Fridericia formula; if the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is taken);
  • Patients with high blood pressure who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (average of BP based on ≥2 measurements), allowing the use of antihypertensive treatment to achieve the above parameters; there have been hypertensive crisis or hypertensive encephalopathy previously;
  • A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
  • Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) those with a history of melena and hematemesis within 3 months;
  • Abnormal coagulation function (INR>1.5×ULN,activated partial thromboplastin time>1.5×ULN), with bleeding tendency;
  • There is obvious hemoptysis within 2 months before screening, or hemoptysis volume is no less than half a teaspoon (2.5ml) per day;
  • Imaging studies have shown that the tumor has invaded important blood vessels or that the patient's tumor has a high probability of invading important blood vessels during treatment and causing fatal bleeding;
  • Thrombosis or embolic events occurred within 6 months prior to the start of treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
  • Currently associated with interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis that may interfere with the assessment and management of immune-related pulmonary toxicity, Organized pneumonia (eg, bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or evidence of active pneumonia or severe impaired lung function on a chest computed tomography (CT) scan during screening, but radiation pneumonitis is allowed in field of radiation: active tuberculosis;
  • There is autoimmune disease or a history of active autoimmune disease which may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis); patients who have skin diseases that do not require systemic treatment such as vitiligo, psoriasis, hair loss, patients who have controlled type 1 diabetes by using insulin, and patients who have completely relieved asthma in childhood and needn't intervention after be adults can be included; Asthmatic patients need bronchodilators for medical intervention cannot be included;
  • Use immunosuppressive agents or systemic hormonal therapy for immunosuppression within 14 days prior to initiation of study treatment (dose > 10 mg/day of prednisone or other therapeutic hormones);
  • Use strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogs) and hyperforin perforatum or strong CYP3A4/CYP2C19 inhibitors within 14 days prior to initiation of study treatment;
  • Have a severe allergic history of any monoclonal antibody, anti-angiogenic targeted drug;
  • Uncontrolled infections during screening;
  • Pregnant or lactating women;
  • Patients refused to undergo a biopsy of the tumor at the time of enrollment and out of the group.
  • Other patients evaluated by physician to be unfit for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase II Study to Explore the Safety and Efficacy of Multiple Target Kinase Inhibitor(mTKI) Combined With Anti-Programmed Death-1(PD-1) Antibody in the Treatment of Advanced Thyroid Cancer

The study is being conducted to evaluate the safety and efficacy of Multiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody in subjects with advanced thyroid cancer.

Read the detailed description

We will recruit four types of advanced thyroid cancer patients. Arm A will enroll the radioactive Iodine-refractory differentiated thyroid cancer(RAIR-DTC). Arm B will recruit the advanced medullary thyroid cancer(MTC). Arm C will include the advanced anaplastic thyroid cancer(ATC). Arm D will include the differentiated thyroid cancer that unsuitable for 131I treatment.

This clinical trial will be conducted under Simon's optimal two-stage design.

For arm A, the first stage needs 8 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 16 patients to achieve a total number of 24 participants enrolled.

For arm B, the first stage needs 8 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 16 patients to achieve a total number of 24 participants enrolled.

For arm C, the first stage needs 13 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 30 patients to achieve a total number of 43 participants enrolled.

For arm D, the first stage needs 8 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 16 patients to achieve a total number of 24 participants enrolled.

Conditions
Thyroid Cancer
Being tested
multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibodyDrug

    Also called mTKI, PD-1 antibody

    Patients receive Multiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody

Study groups in NCT04521348
Study groupRoleWhat they receive
RAIR-DTC armExperimentalMultiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody
Receives: Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody
MTC armExperimentalMultiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody
Receives: Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody
ATC armExperimentalMultiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody
Receives: Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody
DTC unsuitable for RAI armExperimentalMultiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody
Receives: Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody

What is being measured

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

  1. Objective Response Rate(ORR)

    Complete remission rate+ partial remission rate

    Measured: Up to approximately 12 weeks

Secondary outcomes (11)

  1. Duration of Response(DOR)

    Time from the date of first partial remission or complete remission to the date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

    Measured: up to approximately 3 years

  2. Disease Control Rate(DCR)

    Complete remission rate+ partial remission rate+stable disease rate

    Measured: Up to approximately 12 weeks

  3. Time to response(TTR)

    Time from the initiation of the treatment to the first remission

    Measured: up to approximately 12 weeks

  4. Progression Free Survival(PFS)

    Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

    Measured: up to approximately 3 years

  5. Overall survival(OS)

    Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.

    Measured: up to approximately 3 years

  6. 6-month overall survival rate

    proportion of patients who lived 6 months or more since enrollment

    Measured: From the start of treatment to 6 months

  7. 12-month overall survival rate

    proportion of patients who lived 12 months or more since enrollment

    Measured: From the start of treatment to 12 months

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

    incidence of treatment-related AEs and grade3/4 AEs according to CTCAE v4.0

    Measured: from the first drug administration to within 90 days for the last Anti-Programmed Death-1 Antibody dose

  9. Rate of dose suspension, dose reduction and dose termination

    proportion of patients who have experienced dose suspension, dose reduction and dose termination

    Measured: up to approximately 2 years

  10. Rate of dose reduction

    proportion of patients who have experienced dose reduction

    Measured: up to approximately 2 years

  11. Rate of dose termination

    proportion of patients who have experienced dose termination

    Measured: up to approximately 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 posted20 Aug 2020
  2. Study start30 Dec 2019
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521348
Sponsor's protocol ID
Ahead-T210
Status last verified
Jul 2025
First submitted
25 Oct 2019
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Han PZ, Ye WD, Yu PC, Tan LC, Shi X, Chen XF, He C, Hu JQ, Wei WJ, Lu ZW, Qu N, Wang Y, Ji QH, Ji DM, Wang YL. A distinct tumor microenvironment makes anaplastic thyroid cancer more lethal but immunotherapy sensitive than papillary thyroid cancer. JCI Insight. 2024 Mar 7;9(8):e173712. doi: 10.1172/jci.insight.173712.

    PubMed 38478516

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody in people with Thyroid Cancer, run by Fudan University 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 22 inclusion and 25 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 24 Jul 2025. 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?

Objective Response Rate(ORR) (time frame: Up to approximately 12 weeks). 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 NCT04521348, which also lists 1 linked publication.

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 24 Jul 2025.

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