Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 7
- 主要终点
- DFS
研究概览
简要总结
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
详细描述
This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.
Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- •Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
- •Cervical lymph node metastasis can be controlled locally
- •Age 18 to 75 years;
- •Without distant metastasis;
- •Informed consent forms signed;
- •≥6months from the accomplishment of radiation to recurrence
- •previously radiotherapy for only 1 course;
- •ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
- •Sufficient organ function;
- •Undergone endoscopic surgery with negative pathological margin;
排除标准
- •Participation in other interventional clinical trials;
- •Uncontrolled illnesses which will interfere with the ability to undergo therapy;
- •Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
- •Any contradiction to immune and chemotherapy;
- •With serious autoimmune disease;
- •Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
- •Severe allergic reactions to other monoclonal antibodies;
- •History of radioactive particle planting;
- •Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
- •Female patients who are at pregnancy or lactation;
- •Other situations that the researchers believe are not suitable for enrollment
研究组 & 干预措施
The experimental group
Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
干预措施: Immunotherapy,Toripalimab Injection (Drug)
The experimental group
Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
干预措施: Chemotherapy,Gemcitabine based regimen (Drug)
结局指标
主要结局
DFS
时间窗: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
Disease free survival
次要结局
- 1-and 2-year DFS rate(end of 1st year, end of 2nd year)
- 1-and 2-year OS rate(end of 1st year, end of 2nd year)
- OS(From randomization to death of any cause,assessed up to 60 months)
- LRFS(From randomization to local recurrence or death,assessed up to 24 months)
- DMFS(From randomization to distant metastasis or death, assessed up to 24 months)