Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced 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
- 154
- 试验地点
- 7
- 主要终点
- EFS
研究概览
简要总结
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
详细描述
Eligible patients are randomized into the control group and the experimental group.
Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.
Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.
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;
- •Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
- •Cervical lymph node metastasis can be controlled locally;
- •Aged 18 to 75 years;
- •Informed consent forms signed to participate in the trial;
- •Without distant metastasis;
- •≥6months from the accomplishment of radical radiation to recurrence
- •previously only 1 course of radiotherapy;
- •Sufficient organ function;
- •ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.
排除标准
- •Participate in other interventional clinical trials;
- •Uncontrolled illnesses that interfere with the therapy;
- •Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
- •Any contradiction to surgery;
- •With serious autoimmune disease;
- •The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
- •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 not suitable for enrollment
研究组 & 干预措施
The control group
Endoscopic surgery + adjuvant therapy
干预措施: endoscopic surgery (Procedure)
The control group
Endoscopic surgery + adjuvant therapy
干预措施: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy (Drug)
The experimental group
Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
干预措施: endoscopic surgery (Procedure)
The experimental group
Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
干预措施: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy (Drug)
The experimental group
Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
干预措施: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy (Drug)
结局指标
主要结局
EFS
时间窗: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
Event free survival
次要结局
- DFS(From randomization to recurrence, metastasis or death, up to 1 year)
- LRFS(From randomization to local recurrence or death, up to 1 year)
- DMFS(From randomization to distant metastasis or death, up to 1 year)
- pCR(Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery)
- ORR(Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year)
- 1-and 2-year OS rate(one- and two-year)
- DCR(Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year)
- 1-and 2-year PFS rate(one- and two-year)
- OS(Time interval of randomization and death of any cause, up to 5 years)
- DoR(First date of response to the date of progression, up to 5 years)