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

NCT04521348 | Completed Phase 2

• 1 other identifier: Ahead-T210
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  Complete remission rate+ partial remission rate

  Up to approximately 12 weeks

Secondary Outcomes (11)

• Duration of Response(DOR)

  up to approximately 3 years

• Disease Control Rate(DCR)

  Up to approximately 12 weeks

• Time to response(TTR)

  up to approximately 12 weeks

• Progression Free Survival(PFS)

  up to approximately 3 years

• Overall survival(OS)

  up to approximately 3 years

Study Arms (4)

RAIR-DTC arm

EXPERIMENTAL

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

Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody

MTC arm

EXPERIMENTAL

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

Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody

ATC arm

EXPERIMENTAL

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

Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody

DTC unsuitable for RAI arm

EXPERIMENTAL

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

Drug: multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody

Interventions

multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody DRUG

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

Also known as: mTKI, PD-1 antibody

ATC arm; DTC unsuitable for RAI arm; MTC arm; RAIR-DTC arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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):

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• JI DONGMEI, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: August 20, 2020
• Study Start: December 30, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)