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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05830500
Other study ID # ALOT-MTC-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 19, 2023
Est. completion date December 2028

Study information

Verified date April 2023
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date December 2028
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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: 1. Blood routine examination shall meet the following standards (no transfusion within 14 days) : 1. Hemoglobin (Hb) =85g/L; 2. Absolute Neutrophil Count (ANC) =1.5×109/L; 3. Platelet (PLT) =80×109/L; 2. Biochemical examination shall meet the following standards: 1. Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN); 2. Alanine transferase (ALT) and Aspartate transferase (AST) =2.5×ULN; If accompanied by liver metastasis, ALT and AST =5×ULN; 3. 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. Exclusion Criteria: - Complicated diseases and history: 1. 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)]; 2. Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment; 3. Subjects with any severe and/or uncontrolled disease, including: 1. 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)); 2. Active or uncontrolled severe infection (= Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection); 3. 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.;

Study Design


Intervention

Drug:
Anlotinib Hydrochloride Capsule
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously.

Locations

Country Name City State
China Beijing Tongren Hospital Affiliated to Capital Medical University Beijing Beijing
China Hunan Cancer Hospital Changsha Hunan
China Zhejiang Provincial People's Hospital Hangzhou Zhejiang
China Anhui Provincial Cancer Hospital Hefei Anhui
China The First Affiliated Hospital of Kunming Medical University Kunming Yunnan
China Gansu Cancer Hospital Lanzhou Gansu
China Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Nanjing Jiangsu
China Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University) Nanning Guangxi
China Liaoning Cancer Hospital and Institute Shenyang Liaoning
China The First Affiliated Hospital of Hebei North University Shijiazhuang Hebei
China Tianjin Cancer Hospital Tianjin Hebei
China Tianjin People's Hospital Tianjin Tianjin
China Hubei Cancer Hospital Wuhan Hubei
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Shanxi Provincial Tumor Hospital Xi'an Shanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Jiangsu North People's Hospital Yangzhou Jiangsu
China Henan Cancer Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Secondary 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.
Secondary 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. Baseline up to 3 years.
Secondary Overall Survival (OS) From randomization to the time of death from any cause. Baseline up to death event, up to 3 years.
Secondary 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.
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