NCT05830500招募中4 期
A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 19
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.;
研究组 & 干预措施
Anlotinib capsules
Experimental
Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)
干预措施: Anlotinib Hydrochloride Capsule (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Baseline up to 3 years.
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Progression-free Survival (PFS)
时间窗: Baseline up to 3 years.
From the first dose of investigational drug to the date of disease progression or death, whichever occurs first.
次要结局
- Disease-control Rate (DCR)(Baseline up to 3 years.)
- Adverse event rate(Baseline up to 3 years.)
- Duration of Response (DOR)(Baseline up to 3 years.)
- Overall Survival (OS)(Baseline up to death event, up to 3 years.)
研究者
研究点 (19)
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