A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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) :

• 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.

Locations
Other Locations
China
Beijing Tongren Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Gansu Cancer Hospital
RECRUITING
Lanzhou
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
RECRUITING
Nanjing
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
NOT_YET_RECRUITING
Nanning
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
The First Affiliated Hospital of Hebei North University
RECRUITING
Shijiazhuang
Tianjin Cancer Hospital
RECRUITING
Tianjin
Tianjin People's Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Shanxi Provincial Tumor Hospital
NOT_YET_RECRUITING
Xi’an
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Jiangsu North People's Hospital
RECRUITING
Yangzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Time Frame
Start Date: 2023-06-19
Estimated Completion Date: 2028-12
Participants
Target number of participants: 360
Treatments
Experimental: Anlotinib capsules
Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)
No_intervention: Observation
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.).
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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