Induction Chemotherapy of Toripalimab With Docetaxel and Cisplatin Followed by De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- PFS PFS
研究概览
简要总结
Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma (NPC), oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers including EBV-related NPC. Oropharyngeal carcinoma was considered to be similar with NPC in terms of immune environment. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16
- •positive or PCR HPV16 positive
- •T1-2/N1-3M0(except T1N1M0 and single LN<3cm)or T3-4N0-3M0 according to UICC/AJCC 8th staging system
- •No prior anti-tumor treatment
- •Karnofsky Performance Score (KPS)≥70
- •Adequate blood supply
- •Informed consent obtained
排除标准
- •Cannot take contrast-MRI imaging
- •Combined with other malignant tumor (except basal cell carcinoma of skin)
结局指标
主要结局
PFS PFS
时间窗: 2 year
Progression Free Survival
次要结局
未报告次要终点
