Medullary Thyroid CancerPhase 4NCT05830500
Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
A Phase 4 study testing Anlotinib Hydrochloride Capsule in people with Medullary Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 19 sites in China.
Trial summary
This is a real world study aiming to observe the efficacy and safety of Anlotinib capsules in patients with advanced medullary thyroid carcinoma, and to summarize the treatment experience in a broad population of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Medullary Thyroid Cancer
- What is being tested?
- Anlotinib Hydrochloride Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 19 sitesChina
- Study dates
- 19 Jun 2023to Dec 2028
- Phase
- Phase 4
- 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
Who may be able to join
- Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- Patients ≥18 years of age (at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 3 months;
- Patients were pathologically confirmed as inoperable locally advanced or metastatic medullary thyroid carcinoma (MTC), possessing imaging or clinical evidence of disease progression within the first 14 months of enrollment;
- Having at least one measurable lesion (assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
- Major organ functions meet the following criteria within 7 days prior to the treatment:
- Blood routine examination shall meet the following standards (no transfusion within 14 days) :
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- Hemoglobin (Hb) ≥85g/L;
- Absolute Neutrophil Count (ANC) ≥1.5×109/L;
- Platelet (PLT) ≥80×109/L；
- Biochemical examination shall meet the following standards:
- 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；
- Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance rate (CCr) ≥60ml/min；
- 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 until 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 until six months after the end of the study.
Who cannot join
- Complicated diseases and history:
- Patients currently have or had other malignancies within 3 years. Patients with the following two conditions can be included in the group: Continuous 5-year disease-free survival (DFS) was achieved for other malignancies treated with a single operation. Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (the tumor infiltrates the basal membrane)];
- Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;
- Subjects with any severe and/or uncontrolled disease, including:
- Having ≥ grade 2 myocardial ischemia or myocardial infarction or arrhythmia (including QTc ≥450ms (male), QTc ≥470ms (female) and ≥ grade 2 congestive heart failure (classified by New York heart association, NYHA));
- Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection);
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- Renal failure requiring hemodialysis or peritoneal dialysis;
- 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.
- Patients who have previously used anlotinib hydrochloride capsules or similar Vascular Endothelial Growth Factor- Tyrosine Kinase Inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.;
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100005
Xiaohong Chen, +86 13911071002
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Jie Chen, PhD, +86 13607431251, 446777708@qq.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 314408
Minghua Ge, PhD, +86 13605813782, gemingh@163.com
- Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Shengying Wang, PhD, +86 18963790387
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Ruochuan Cheng, PhD, + 86 13708467986, cruochuan@foxmail.com
- Recruiting
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
Jun Wang, PhD, +86 13893338170
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Jianfeng Sang, PhD, +86 13382033138, 32582999@qq.com
- Not yet recruiting
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
Nanning, Guangxi, 530021
Jian Xu, PhD, +86 13978611163, 1597280804@qq.com
- Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110801
Zhendong Li, PhD, +86 18900917937, 1349946150@qq.com
- Recruiting
The First Affiliated Hospital of Hebei North University
Shijiazhuang, Hebei, 050051
Xiaoling Shang, PhD, +86 15530396553
- Recruiting
Tianjin Cancer Hospital
Tianjin, Hebei, 300181
Xiangqian Zheng, PhD, +86 18622220506, xiangqian_zheng@163.com
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300122
Ming Gao, PhD, + 86 18622221110, gaoming68@aliyun.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xingrui Li, PhD, +86 13507150698, Lixingrui07@gmail.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Youhua Zhu, PhD, +86 13098899772, 453110015@qq.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Shaoqiang Zhang, PhD, +86 18991232178, entsqzhang@163.com
- Not yet recruiting
Shanxi Provincial Tumor Hospital
Xi’an, Shanxi, 710065
Yuan An, PhD, +86 15389233663
- Recruiting
Jiangsu North People's Hospital
Yangzhou, Jiangsu, 225003
Haizhong Zhou, PhD, +86 18051062358, 475469305@qq.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Jianwu Qin, PhD, +86 13598802366, qinjianwu62@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xinguang Qiu, PhD, +86 13803710710, qxg2000@126.com
About this study
Official title: A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma
This is a real world study aiming to observe the efficacy and safety of Anlotinib capsules in patients with advanced medullary thyroid carcinoma, and to summarize the treatment experience in a broad population of patients.
- Conditions
- Medullary Thyroid Cancer
- Being tested
- Anlotinib Hydrochloride Capsule
- Medical subject headings
- Carcinoma, Medullary
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 simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib capsules | Experimental | Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle) Receives: Drug: Anlotinib Hydrochloride Capsule |
| Observation | No intervention | Observational group: prospectively and retrospectively collect data for patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors (including Rearranged during transfection (RET) inhibitors, etc.). |
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 of investigational drug to the date of 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 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 death event, 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 posted26 Apr 2023
- Study start19 Jun 2023
- Primary completionJun 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 Medullary Thyroid CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 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
- NCT05830500
- Sponsor's protocol ID
- ALOT-MTC-1
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 25 Jul 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05830500
- Acronym / sponsor ID
- ALOT-MTC-1
- Conditions
- Medullary Thyroid Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Apr 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.
This is a real world study aiming to observe the efficacy and safety of Anlotinib capsules in patients with advanced medullary thyroid carcinoma, and to summarize the treatment experience in a broad population of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib capsules | Experimental | Drug: Anlotinib Hydrochloride CapsuleAnlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle) |
| Observation | No intervention | –Observational group: prospectively and retrospectively collect data for patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors (including Rearranged during transfection (RET) inhibitors, etc.). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- Patients ≥18 years of age (at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 3 months;
- Patients were pathologically confirmed as inoperable locally advanced or metastatic medullary thyroid carcinoma (MTC), possessing imaging or clinical evidence of disease progression within the first 14 months of enrollment;
- Having at least one measurable lesion (assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
- Major organ functions meet the following criteria within 7 days prior to the treatment:
Key exclusion criteria (9 listed)
- Complicated diseases and history:
- 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.
- Patients who have previously used anlotinib hydrochloride capsules or similar Vascular Endothelial Growth Factor- Tyrosine Kinase Inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, 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 simultaneously. | Drug | Anlotinib capsules |
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 of investigational drug to the date of 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 death event, 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 25 Jul 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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anlotinib Hydrochloride Capsule in people with Medullary Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 19 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 14 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 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 25 Jul 2023.