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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.19 sites in 1 country360 target enrollmentJune 19, 2023

ConditionsMedullary Thyroid Cancer

InterventionsAnlotinib Hydrochloride Capsule

DrugsAnlotinib Hydrochloride Capsule

Overview

Phase: Phase 4
Intervention: Anlotinib Hydrochloride Capsule
Conditions: Medullary Thyroid Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 360
Locations: 19
Primary Endpoint: Overall Response Rate (ORR)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 19, 2023

End Date

December 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

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:

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.;