NCT04879654招募中2 期
Phase II, Single-arm, Prospective Clinical Study of Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of Sinonasal Malignant Mucosal Melanoma（SNMM） After Endoscopic Surgery
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Phase II, single-arm, prospective clinical study of Toripalimab(a PD-1 antibody) combined with radiotherapy and chemotherapy in the treatment of sinonasal malignant mucosal melanoma after endoscopic surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Pathologically diagnosed as sinonasal malignant mucosal melanoma, locally resectable and no contraindication for surgery or radiation. 2.T3 and T
- •3.Age ≥18 year-old 4.No distant metastasis 5.No head and neck radiation and systemic anti-tumor therapy performed in the past 5 years. 6.The performance status of the Eastern Cooperative Oncology Group(ECOG) is 0-2 points and surgery after general anesthesia and postoperative radiation could be tolerated. 7.Accepted organ function
排除标准
- •Patients who refused to sign informed consent.
- •Have received radioactive seed implantation in the treatment area.
- •Suffer from uncontrolled disease which could interfere treatment.
- •Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.).
- •The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on. 6.The patients have autoimmune diseases.
- •The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before the first administration;
- •Severe allergic reaction to other monoclonal antibodies;
- •Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment;
- •Live vaccines have been inoculated within 4 weeks before the first administration or during the study period;
- •The patient has any situation that may hinder study compliance or the safety during the study period.
- •Existence of serious neurological or psychiatric diseases, such as dementia and seizures;
- •Uncontrolled active infection.
- •Pregnant or breastfeeding women.
- •Those who have no personal freedom and independent capacity for civil conduct;p.
- •There are other situations that are not suitable for entry into the study.
研究组 & 干预措施
endonasal endoscopic surgery with adjuvant therapy
Experimental
endonasal endoscopic surgery followed by Toripalimab,radiotherapy and/or chemotherapy
干预措施: endoscopic surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: From date of first treatment until the date of death from any cause,through study completion,up to 3 years.]
3 year Overall Survival rate
次要结局
- progression free survival(From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 3 years.)
研究者
Hongmeng Yu
MD,PhD
Eye & ENT Hospital of Fudan University
研究点 (1)
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