A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willing to give an informed consent for the study.
- •Males or females aged 18 to 80 years.
- •Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to
- •Pathologically (histologically or cytologically) confirmed, non-metastatic diagnosis of squamous cell carcinoma of head and neck (SCCHN).
- •Achievement of major pathological reaponse (MPR) after surgery with neoadjuvant immunotherapy combined chemotherapy.
- •Adequate bone marrow, liver, and renal function:
- •Absolute neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 9.0g/dL, platelets ≥100000/μL; ALT and AST < 2.5× upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN； Creatinine clearance ≥ 60 ml/min； APTT≤ 1.5×ULN.
排除标准
- •Participant has metastatic/unresectable SCCHN.
- •Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
- •With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
- •With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
- •With active infection requiring systemic therapy.
- •Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
- •Any other factors that are not suitable for inclusion in this study judged by investigators.
研究组 & 干预措施
Toripalimab
toripalimab, IV, 240mg, q3w, for 15 cycles
干预措施: Toripalimab (Drug)
SOC CCRT or radiotherapy
Standard concurrent radiochemotherapy or postoperative radiotherapy
干预措施: Radiation Therapy (Radiation)
SOC CCRT or radiotherapy
Standard concurrent radiochemotherapy or postoperative radiotherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
Disease Free Survival
时间窗: up to 4 years
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
次要结局
- Toxicity Adverse events(up to 1 year)
- Over survival (OS)(up to 4 years)