A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pathological response rate
研究概览
简要总结
Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.
详细描述
Patients with resectable melanoma can benefit from neoadjuvant therapy, including improved surgical outcomes, precise management of patients based on neoadjuvant response, and analysis of resistance mechanisms through histological sections for subsequent treatment. At present, there have been a number of clinical trials exploring the effect of neoadjuvant regimens for melanoma, and some published results have shown that neoadjuvant therapy can lead to a higher pathological response rate, thereby improving the RFS of patients.
In the past, this site has carried out a clinical study of Camrelizumab combined with Apatinib and Temozolomide for first-line treatment of unresectable acral melanoma, with a high preliminary clinical response rate and safety. Based on this, this study intends to evaluate the neoadjuvant treatment of completely resectable melanoma with Camrelizumab combined with Apatinib and Temozolomide in patients with stage III and IIB, IIC high-risk melanoma. To comprehensively evaluate the short-term and long-term benefits of neoadjuvant therapy and provide an important reference for neoadjuvant treatment strategies in the acral melanoma population.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:18-75 years, male or female.
- •Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
- •Has not received any systematic anti-tumor drug treatment.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Adequate organ function.
- •Life expectancy of greater than 12 weeks.
- •Patient has given written informed consent.
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- •Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.
- •Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Subjects with any active autoimmune disease or history of autoimmune disease
- •Patients with any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease;
- •Received a live vaccine within 4 weeks of the first dose of study medication.
- •Pregnancy or breast feeding.
- •Decision of unsuitableness by principal investigator or physician-in charge.
研究组 & 干预措施
Neoadjuvant/adjuvant therapy
Drug: Camrelizumab
Drug: Apatinib mesylate
Drug: Temozolomide Injection
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Pathological response rate
时间窗: Week 8-12
The primary endpoint is the pathological response rate at surgery after neoadjuvant study treatment. The pathological response is categorised thus: Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen Near complete pathological response - (near pCR) - \<10% viable tumour Partial pathological response (pPR) - 10%-50% viable tumour No pathological response (pNR) - \>50% viable tumour
次要结局
- Objective Response Rate(Months 0-6)
- Recurrence-free survival(1year,2year)
- Overall survival(10 years)
- Patient reported quality of life(90 days from last dose of study treatment)
- Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.(90 days from last dose of study treatment)
研究者
Jun Guo
Professor
Peking University Cancer Hospital & Institute