Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.
详细描述
Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects are not limited by gender, age from 18 to 75 years old;
- •Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
- •Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
- •ECOG score 0-1;
- •without distant metastasis;
- •received induction chemotherapy plus immunotherapy, followed by surgery
- •The expected survival is expected to be no less than 6 months.
- •No contraindications to chemotherapy, immunotherapy, and radiotherapy;
排除标准
- •Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- •Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
- •Previously experienced head and neck radiation therapy;
- •Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;
- •Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;
- •Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
结局指标
主要结局
Disease-free survival
时间窗: 2 years
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.
次要结局
- Overall survival(2 years)
- Local-Regional failure survival(2 years)
- Toxicity Adverse events(2 years)