To hear about similar clinical trials, please enter your email below
Trial Title:
Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
NCT ID:
NCT05994365
Condition:
Thyroid Neoplasms
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib Hydrochloride Capsule
Description:
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both
tumor angiogenesis and tumor cell proliferation.
Arm group label:
Anlotinib group
Summary:
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules
in patients with locally advanced or metastatic radioiodine-refractory differentiated
thyroid carcinoma in the real world, and to summarize the treatment experience in a broad
population.
Criteria for eligibility:
Study pop:
Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
Patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients voluntarily participate in this study, sign the informed consent form and
had good compliance;
- Aged 18 ~ 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG
PS) score: 0~1; more than 6 months of expected survival ;
- Histopathologically confirmed locally advanced or metastatic differentiated thyroid
cancer, radiographically documented disease progression within 18 months of absence
of radioactive iodine (RAI) therapy;
- Meet any of the following:
1. Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the
presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH)
elevation (≥ 30 mIU/L). The definition of no iodine uptake:
1. no iodine uptake initially;
2. exist of iodine uptake initially while lost subsequently;
3. partially uptake;
4. progression disease despite iodine uptake.
2. The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at
least 3 months.
3. Radiographically documented disease progression within 18 months of RAI therapy
despite the presence of iodine-131 affinity at the time of RAI therapy;
- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumours (RECIST) 1.1.
- Major organ functions meet the following criteria within 7 days prior to treatment:
1. Blood routine test criteria (14 days without blood transfusion):
1. Hemoglobin (HB) ≥ 85 g/L;
2. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
3. Platelet (PLT) ≥ 80 × 10^9/L
2. Biochemical tests need to meet the following criteria:
1. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);
2. Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2
.5×ULN, ALT and AS if liver metastases T ≤ 5 ×ULN;
3. Serum creatinine (Cr) ≤ 1 .5 ×ULN or creatinine clearance (CCr) ≥ 60
Ml/min;
- Females of childbearing potential should agree to use contraceptive measures (such
as intrauterine device, contraceptives or condoms) during the study and within 6
months after the end of the study; have a negative serum or urine pregnancy test
within 7 days before study enrollment and must be non-lactating patients; and males
should agree to use contraceptive measures during the study and within 6 months
after the end of the study period.
Exclusion Criteria:
- Comorbidities and medical history:
1. A history of or concurrent with other malignancies within the past 3 years.
Patients were eligible if they had disease-free survival (DFS) for 5
consecutive years in other malignancies treated by single surgery; Cured
cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder
tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor
infiltrating basement membrane)];
2. Major surgical treatment, open biopsy, or significant traumatic injury within
28 days before the start of study treatment;
3. Subjects with any severe and/or uncontrolled illness, including:
1. Patients with ≥ grade 2 myocardial ischemia or myocardial infarction,
arrhythmia (including Corrected QT Interval (QTc)≥450ms(male), QTc≥
470ms(female)) and ≥ grade 2 congestive heart failure (NYHA
classification);
2. Severe active or uncontrolled infection (≥ grade 2 infection according to
Common Terminology Criteria for Adverse Events (CTCAE) );
3. Renal failure requiring hemodialysis or peritoneal dialysis;
- Patients with concomitant diseases that seriously endanger the safety of patients or
affect the completion of the study, or patients who are considered to be unsuitable
for enrollment for other reasons according to the judgment of the investigators.
- patients with previous treatment with anlotinib hydrochloride capsules or similar
vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI)
small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or
sorafenib, etc.;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100007
Country:
China
Status:
Recruiting
Contact:
Last name:
Yansong Lin, PhD
Phone:
+86 13671116837
Email:
linys@pumch.cn
Facility:
Name:
Tianjin People's Hospital
Address:
City:
Tianjin
Zip:
300122
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Gao, PhD
Phone:
+ 86 18622221110
Email:
gaoming68@aliyun.com
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangqian Zheng, PhD
Phone:
+86 18622220506
Email:
xiangqian_zheng@163.com
Start date:
August 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05994365
