NCT04778956招募中3 期
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
Sun Yat-sen University7 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2021年3月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 218
- 试验地点
- 7
- 主要终点
- Disease-free survival
研究概览
简要总结
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
详细描述
Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The recurrence time is more than 6 months from the end of radiotherapy.
- •Histologically confirmed recurrent nasopharyngeal carcinoma.
- •Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
- •Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
- •Given written informed consent.
排除标准
- •Karnofsky Performance Status (KPS) ≤
- •Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- •Has known subjects with other malignant tumors.
- •Has participated in other drug trials within 3 months of planned start of study treatment.
- •Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- •Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
- •Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
- •Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- •Has received a live vaccine within 4 weeks of planned start of study treatment.
- •Pregnancy or breast feeding.
- •Cannot complete regular follow-up.
研究组 & 干预措施
Toripalimab plus salvage surgery
Experimental
- Toripalimab: Toripalimab treatment before and after salvage surgery.
- Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
干预措施: Toripalimab (Drug)
Toripalimab plus salvage surgery
Experimental
- Toripalimab: Toripalimab treatment before and after salvage surgery.
- Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
干预措施: salvage surgery (Procedure)
Salvage surgery alone
Active Comparator
- Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
干预措施: salvage surgery (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.
次要结局
- Objective Response Rate(3-5 weeks)
- Overall Survival(2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(up to 2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(up to 2 years)
- Major Pathological Response Rate(4-6 weeks)
- Distant Metastasis-Free Survival(2 years)
- Locoregional Relapse-Free Survival(2 years)
研究者
Ming-Yuan Chen
Professor, Chief Doctor
Sun Yat-sen University
研究点 (7)
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