Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Tumor Response Rate
研究概览
简要总结
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.
详细描述
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
- •Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- •ECOG performance status of 0 or 1
- •Adequate organ and marrow function defined by study-specified laboratory tests
- •Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
- •Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer
排除标准
- •Patients who have received other systems for anti-tumor treatment
- •Patients who have previously received targeted or immunotherapy
- •Need for urgent or emergent nephrectomy to relieve symptoms
- •Current use of immunosuppressive agents
- •Pregnant or breastfeeding women
- •History of autoimmune disease or syndrome
研究组 & 干预措施
Neoadjuvant arm
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
干预措施: Toripalimab (Drug)
Neoadjuvant arm
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
干预措施: Axitinib (Drug)
结局指标
主要结局
Objective Tumor Response Rate
时间窗: 3 month
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
次要结局
- Safety assessed by adverse events(through study completion, an average of 4 months)
- Perioperative complication rate(from perioperative to 90 days after surgery)
- Quality of Life questionnaire(Baseline, 3 weeks, 12 weeks and after surgery)
- Tumor complexity changing by total R.E.N.A.L. score(Baseline, 12 weeks)