Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Progress-free survival(PFS)
研究概览
简要总结
Through open-label, single-center, 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 locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
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
- •Histologically confirmed recurrent nasopharyngeal carcinoma
- •The recurrence time is more than 6 months from the end of radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team.
- •Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
- •Given written informed consent.
排除标准
- •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.
- •Local recurrence of nasopharyngeal carcinoma with distant metastasis
研究组 & 干预措施
Tirelizumab plus salvage surgery
Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
干预措施: Tirelizumab (Drug)
Tirelizumab plus salvage surgery
Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
干预措施: salvage surgery (Procedure)
salvage surgery alone
Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
干预措施: salvage surgery (Procedure)
结局指标
主要结局
Progress-free survival(PFS)
时间窗: 2 years
Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause
次要结局
- Overall survival(OS)(2 years)
- Locoregional failure-free survival(LRRFS)(2 years)
- Distant metastasis-free survival(DMFS)(2 years)
- Incidence of treatment related complications(2 years)
研究者
Dehui Wang
Professor
Eye & ENT Hospital of Fudan University