NCT04612894Unknown2 期
The Efficacy and Safety of Anti-PD-1 Antibody Camrelizumab Combined With Apatinib for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer: a Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient volunteered to participate in the study and signed an informed consent form;
- •Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis;
- •Preoperative assessment of locally advanced thyroid cancer (unable to achieve R0/1 resection or T4 disease);
- •Have at least one measurable lesion (RECIST 1.1);
- •Age>=14 years, Eastern Cooperative Oncology Group (ECOG) score 0-1;
- •Patient agree to receive surgery/ core needle biopsy before and after neoadjuvant treatment.
- •The main organ functions meet the criteria before treatment.
排除标准
- •Patients who have previously been treated with immune checkpoint inhibitors (including but not limited to nivolizumab, pembrolizumab, teriplizumab, sintilizumab, etc.);
- •Received external radiation therapy or iodine-131 therapy within the past 28 days; or planned systemic anti-tumor therapy during this study;
- •Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.);
- •With other uncontrolled / under treatment malignancies;
- •Those who have multiple factors (such as inability to swallow) that affect oral medication;
- •Patients with any severe and / or uncontrolled illness,
- •Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding;
- •According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.
研究组 & 干预措施
Neoadjuvant Camrelizumab + Apatinib
Experimental
Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
干预措施: Camrelizumab and Apatinib (Drug)
Neoadjuvant Camrelizumab + Apatinib
Experimental
Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
干预措施: surgery (Procedure)
Neoadjuvant Camrelizumab + Apatinib
Experimental
Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
干预措施: core needle biopsy (Procedure)
结局指标
主要结局
Objective response rate
时间窗: up to 24 weeks
ORR
次要结局
- Disease control rate(at the time point of 6 weeks)
- Adverse Events(from the first drug administration to within 90 days after surgery)
- R0/1 resection rate(at the time of surgery)
- Overall survival(up to 3 years)
研究者
研究点 (1)
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