Clinical trial NCT05830500: Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
Official title: A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Medullary Thyroid Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.;

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Baseline up to 3 years.
measure: Progression-free Survival (PFS)
timeFrame: Baseline up to 3 years.
Secondary outcomes:
measure: Disease-control Rate (DCR)
timeFrame: Baseline up to 3 years.
measure: Duration of Response (DOR)
timeFrame: Baseline up to 3 years.
measure: Overall Survival (OS)
timeFrame: Baseline up to death event, up to 3 years.
measure: Adverse event rate
timeFrame: Baseline up to 3 years.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: Gansu Cancer Hospital
state: Gansu
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
state: Guangxi
city: Shijiazhuang
country: China
facility: The First Affiliated Hospital of Hebei North University
state: Hebei
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
state: Jiangsu
city: Yangzhou
country: China
facility: Jiangsu North People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Provincial Tumor Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References: