Thyroid NeoplasmsNCT05994365
Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
An observational study of Thyroid Neoplasms, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
Trial summary
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Anlotinib Hydrochloride Capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 380 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2023to Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Patients
Who may be able to join
- Patients voluntarily participate in this study, sign the informed consent form and had good compliance;
- Aged 18 ~ 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; more than 6 months of expected survival ;
- Histopathologically confirmed locally advanced or metastatic differentiated thyroid cancer, radiographically documented disease progression within 18 months of absence of radioactive iodine (RAI) therapy;
- Meet any of the following:
- Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH) elevation (≥ 30 mIU/L). The definition of no iodine uptake:
- no iodine uptake initially;
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- exist of iodine uptake initially while lost subsequently;
- partially uptake;
- progression disease despite iodine uptake.
- The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months.
- Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
- Major organ functions meet the following criteria within 7 days prior to treatment:
- Blood routine test criteria (14 days without blood transfusion):
- Hemoglobin (HB) ≥ 85 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet (PLT) ≥ 80 × 10^9/L
- Biochemical tests need to meet the following criteria:
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2 .5×ULN, ALT and AS if liver metastases T ≤ 5 ×ULN;
- Serum creatinine (Cr) ≤ 1 .5 ×ULN or creatinine clearance (CCr) ≥ 60 Ml/min;
- Females of childbearing potential should agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study and within 6 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating patients; and males should agree to use contraceptive measures during the study and within 6 months after the end of the study period.
Who cannot join
- Comorbidities and medical history:
- A history of or concurrent with other malignancies within the past 3 years. Patients were eligible if they had disease-free survival (DFS) for 5 consecutive years in other malignancies treated by single surgery; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of study treatment;
- Subjects with any severe and/or uncontrolled illness, including:
- Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including Corrected QT Interval (QTc)≥450ms(male), QTc≥ 470ms(female)) and ≥ grade 2 congestive heart failure (NYHA classification);
- Severe active or uncontrolled infection (≥ grade 2 infection according to Common Terminology Criteria for Adverse Events (CTCAE) );
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- Renal failure requiring hemodialysis or peritoneal dialysis;
- Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study, or patients who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators.
- patients with previous treatment with anlotinib hydrochloride capsules or similar vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or sorafenib, etc.;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100007
Yansong Lin, PhD, +86 13671116837, linys@pumch.cn
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300122
Ming Gao, PhD, + 86 18622221110, gaoming68@aliyun.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300181
Xiangqian Zheng, PhD, +86 18622220506, xiangqian_zheng@163.com
About this study
Official title: A Real-world Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population.
- Conditions
- Thyroid Neoplasms
- Being tested
- Anlotinib Hydrochloride Capsule
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Hydrochloride CapsuleDrug
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib group | Anlotinib hydrochloride capsules: 12 mg once daily for 2 weeks, followed by a discontinuation of 1 week (21 days as a cycle) Receives: Drug: Anlotinib Hydrochloride Capsule | |
| Observation group | Observation: prospectively and retrospectively collect data of patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Measured: Baseline up to 3 years.
Progression-free Survival (PFS)
From the first dose to the date of objective disease progression or death, whichever occurs first.
Measured: Baseline up to 3 years.
Secondary outcomes (4)
Disease-control Rate (DCR)
The proportion of subjects response of CR, PR, or stable disease (SD), subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks.
Measured: Baseline up to 3 years.
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 3 years.
Overall Survival (OS)
From randomization to the time of death from any cause.
Measured: Baseline up to 3 years.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994365
- Sponsor's protocol ID
- A LOT-DTC-1
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05994365
- Acronym / sponsor ID
- A LOT-DTC-1
- Conditions
- Thyroid Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib group | – | Drug: Anlotinib Hydrochloride CapsuleAnlotinib hydrochloride capsules: 12 mg once daily for 2 weeks, followed by a discontinuation of 1 week (21 days as a cycle) |
| Observation group | – | –Observation: prospectively and retrospectively collect data of patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Patients
Key inclusion criteria (22 listed)
- Patients voluntarily participate in this study, sign the informed consent form and had good compliance;
- Aged 18 ~ 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; more than 6 months of expected survival ;
- Histopathologically confirmed locally advanced or metastatic differentiated thyroid cancer, radiographically documented disease progression within 18 months of absence of radioactive iodine (RAI) therapy;
- Meet any of the following:
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Key exclusion criteria (9 listed)
- Comorbidities and medical history:
- Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study, or patients who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators.
- patients with previous treatment with anlotinib hydrochloride capsules or similar vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or sorafenib, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib Hydrochloride CapsuleAnlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation. | Drug | Anlotinib group |
Primary outcome
Overall Response Rate (ORR)
Time frame: Baseline up to 3 years.
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Progression-free Survival (PFS)
Time frame: Baseline up to 3 years.
From the first dose to the date of objective disease progression or death, whichever occurs first.
4 secondary outcomes
Disease-control Rate (DCR)
Time frame: Baseline up to 3 years.
Duration of Response (DOR)
Time frame: Baseline up to 3 years.
Overall Survival (OS)
Time frame: Baseline up to 3 years.
Adverse event rate
Time frame: Baseline up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 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 22 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Contact Ming Gao, PhD (+ 86 18622221110, gaoming68@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Baseline up to 3 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?
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 16 Aug 2023.