NCT05350891招募中2 期
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 8
- 主要终点
- progression free survival
研究概览
简要总结
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
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
- •Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
- •AJCC rT1-T4 which can be surgically removed.
- •Age ≥18 years old.
- •Informed consent signed.
- •With or without lymph node metastasis, which can be surgically removed.
- •No distant metastasis.
- •≥6 months from the end of initial radiotherapy to recurrence.
- •Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. d) Renal function: serum creatinine ≤ 1.5 times ULN.
- •ECOG score 0-
- •general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.
排除标准
- •Evidence of distant metastasis or leptomeningel disease (LMD).
- •Have received radioactive seed implantation in the treatment area.
- •Suffer from uncontrolled disease which could interfere with 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.
- •The patients have autoimmune diseases.
- •The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other), 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.
- •There are other situations that are not suitable for entry into the study.
结局指标
主要结局
progression free survival
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years.
2 year progression free survival
次要结局
- Overall survival(From date of enrollment until the date of death from any cause,through study completion,up to 2 years.)
研究者
Hongmeng Yu
Principal Investigator, Professor
Eye & ENT Hospital of Fudan University
研究点 (8)
Loading locations...
相似试验
尚未招募
不适用
A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal CarcinomaRecurrent Nasopharyngeal CarcinomaNCT05432219Eye & ENT Hospital of Fudan University20
招募中
不适用
Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal CarcinomaSurgeryRadiotherapyNasopharyngeal CarcinomaNCT06688760Ming-Yuan Chen86
尚未招募
不适用
Outcomes following full versus selective functional endoscopic sinus surgeryChronic RhinosinusitisACTRN12618000925246Yuresh Naidoo50
已完成
不适用
Efficacy of nasogastric and endotracheal tube securement devices, preventative dressings and topical skin applications for reducing device-related pressure injuries in intensive care patients; a pilot studyACTRN12616001174471Queensland University of Technology100
已完成
不适用
Comparison of transnasal oesophagoscopy versus standard care for patients presenting with throat symptomsISRCTN68055393Royal Free Hampstead NHS Trust (UK)50