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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib capsules | Experimental | Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle) |
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| 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.). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride Capsule | Drug | Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR). | 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. | Baseline up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline up to 3 years. |
| Duration of Response (DOR) |
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Inclusion Criteria:
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) :
Biochemical examination shall meet the following standards:
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.
Exclusion Criteria:
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:
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.;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Not yet recruiting | Hefei | Anhui | 230031 | China |
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From the date that CR or PR are first occurred to the date of disease progression or death, whichever occurs first.
| Baseline up to 3 years. |
| Overall Survival (OS) | From randomization to the time of death from any cause. | 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). | Baseline up to 3 years. |
| Beijing Tongren Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| Gansu Cancer Hospital | Recruiting | Lanzhou | Gansu | 730050 | China |
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| Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University) | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| The First Affiliated Hospital of Hebei North University | Recruiting | Shijiazhuang | Hebei | 050051 | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Hebei | 300181 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
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| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Jiangsu North People's Hospital | Recruiting | Yangzhou | Jiangsu | 225003 | China |
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| Liaoning Cancer Hospital and Institute | Recruiting | Shenyang | Liaoning | 110801 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| Shanxi Provincial Tumor Hospital | Not yet recruiting | Xi’an | Shanxi | 710065 | China |
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| Tianjin People's Hospital | Recruiting | Tianjin | Tianjin Municipality | 300122 | China |
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| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 314408 | China |
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| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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