Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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

Qualifiers

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);

Disqualifiers

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;

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);

Trial design

Treatments tested in this trial

  • Anlotinib Hydrochloride Capsule

Treatment groups

360 Participants
are divided into 2 treatment groups

Locations

19
Anhui Provincial Cancer Hospital230031, HefeiAnhui, China
Beijing Tongren Hospital Affiliated to Capital Medical University100005, BeijingBeijing Municipality, China
Gansu Cancer Hospital730050, LanzhouGansu, China
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)530021, NanningGuangxi, China

Sponsors and collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Lead sponsor