NCT05011227招募中2 期
A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Overall Survival
研究概览
简要总结
To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of 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
- •Pathologically confirmed recurrent nasopharyngeal carcinoma
- •American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent 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 massive hemorrhage risk recently
- •No distant metastasis
- •≥6 months from initial radiotherapy to recurrence
- •Radical radiation only once
- •Sufficient organ function
- •Eastern Cooperative Oncology Group score 0-2
排除标准
- •With a history of allergic to platinum drugs and similar compounds
- •Evidence of distant metastasis or radiation encephalopathy or leptomeningeal 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
研究组 & 干预措施
Camrelizumab and chemotherapy combined with endoscopic surgery
Experimental
Camrelizumab and chemotherapy combined with endoscopic surgery
干预措施: Camrelizumab (Drug)
Camrelizumab and chemotherapy combined with endoscopic surgery
Experimental
Camrelizumab and chemotherapy combined with endoscopic surgery
干预措施: Chemotherapy (Drug)
Camrelizumab and chemotherapy combined with endoscopic surgery
Experimental
Camrelizumab and chemotherapy combined with endoscopic surgery
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, up to 4 years.
2 year Overall Survival rate
次要结局
- Local recurrence free survival(From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.)
- distant metastasis free survival(From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.)
- Progression free survival(From date of first treatment until the date of disease progression or death from any cause, up to 4 years.)
- Rate of negative margin(At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.)
- pathologic complete remission(At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.)
研究者
研究点 (7)
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