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Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

Primary Purpose

Medullary Thyroid Cancer

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anlotinib Hydrochloride Capsule
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medullary Thyroid Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) : 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. 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: 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)); Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection); 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.;

Sites / Locations

  • Anhui Provincial Cancer Hospital
  • Beijing Tongren Hospital Affiliated to Capital Medical UniversityRecruiting
  • Gansu Cancer HospitalRecruiting
  • Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
  • The First Affiliated Hospital of Hebei North UniversityRecruiting
  • Tianjin Cancer HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Hubei Cancer HospitalRecruiting
  • Hunan Cancer Hospital
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing UniversityRecruiting
  • Jiangsu North People's HospitalRecruiting
  • Liaoning Cancer Hospital and InstituteRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Shanxi Provincial Tumor Hospital
  • Tianjin People's HospitalRecruiting
  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Zhejiang Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Anlotinib capsules

Observation

Arm Description

Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)

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.).

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Progression-free Survival (PFS)
From the first dose of investigational drug to the date of disease progression or death, whichever occurs first.

Secondary Outcome Measures

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).
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.
Overall Survival (OS)
From randomization to the time of death from any cause.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Full Information

First Posted
April 14, 2023
Last Updated
July 24, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05830500
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medullary Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib capsules
Arm Type
Experimental
Arm Description
Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)
Arm Title
Observation
Arm Type
No Intervention
Arm Description
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.).
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride Capsule
Intervention Description
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Time Frame
Baseline up to 3 years.
Title
Progression-free Survival (PFS)
Description
From the first dose of investigational drug to the date of disease progression or death, whichever occurs first.
Time Frame
Baseline up to 3 years.
Secondary Outcome Measure Information:
Title
Disease-control Rate (DCR)
Description
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).
Time Frame
Baseline up to 3 years.
Title
Duration of Response (DOR)
Description
From the date that CR or PR are first occurred to the date of disease progression or death, whichever occurs first.
Time Frame
Baseline up to 3 years.
Title
Overall Survival (OS)
Description
From randomization to the time of death from any cause.
Time Frame
Baseline up to death event, up to 3 years.
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
Baseline up to 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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. 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: 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)); Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection); 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.;
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengying Wang, PhD
Phone
+86 18963790387
Facility Name
Beijing Tongren Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohong Chen
Phone
+86 13911071002
Facility Name
Gansu Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang, PhD
Phone
+86 13893338170
Facility Name
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xu, PhD
Phone
+86 13978611163
Email
1597280804@qq.com
Facility Name
The First Affiliated Hospital of Hebei North University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Shang, PhD
Phone
+86 15530396553
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Hebei
ZIP/Postal Code
300181
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangqian Zheng, PhD
Phone
+86 18622220506
Email
xiangqian_zheng@163.com
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwu Qin, PhD
Phone
+86 13598802366
Email
qinjianwu62@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinguang Qiu, PhD
Phone
+86 13803710710
Email
qxg2000@126.com
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingrui Li, PhD
Phone
+86 13507150698
Email
Lixingrui07@gmail.com
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youhua Zhu, PhD
Phone
+86 13098899772
Email
453110015@qq.com
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410031
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Chen, PhD
Phone
+86 13607431251
Email
446777708@qq.com
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Sang, PhD
Phone
+86 13382033138
Email
32582999@qq.com
Facility Name
Jiangsu North People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haizhong Zhou, PhD
Phone
+86 18051062358
Email
475469305@qq.com
Facility Name
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Li, PhD
Phone
+86 18900917937
Email
1349946150@qq.com
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoqiang Zhang, PhD
Phone
+86 18991232178
Email
entsqzhang@163.com
Facility Name
Shanxi Provincial Tumor Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710065
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan An, PhD
Phone
+86 15389233663
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300122
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Gao, PhD
Phone
+ 86 18622221110
Email
gaoming68@aliyun.com
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruochuan Cheng, PhD
Phone
+ 86 13708467986
Email
cruochuan@foxmail.com
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
314408
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghua Ge, PhD
Phone
+86 13605813782
Email
gemingh@163.com

12. IPD Sharing Statement

Learn more about this trial

Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

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