Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- complete response rate
研究概览
简要总结
patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.
详细描述
patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.
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
- •Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification;
- •Tumor is morphlogically confirmed;
- •CPS>1 (22C3 clone);
- •ECOG 0-2;
- •Age above 18 years;
- •Signed Informed consent form.
排除标准
- •Cancer of nasopharynx;
- •Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;
- •Stages I or II;
- •ECOG>=3.
研究组 & 干预措施
Experimental arm
3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
complete response rate
时间窗: through study completion, an average of 3 years
rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy
progression-free survival
时间窗: through study completion, an average of 3 years
Time from start of treatment to radiological disease progression
次要结局
- overall survival(through study completion, an average of 3 years)
- Organ-preserving treatment rate(through study completion, an average of 3 years)
- objective response rate(through study completion, an average of 3 years)