Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- MPR
研究概览
简要总结
This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck;
- •Resectable or potentially resectable lesion;
- •ECOG PS 0-1;
- •Age >18 years old;
- •At least one target lesion according to RECIST 1.1;
- •Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;
排除标准
- •Distant metastasis;
- •Second malignancy within 5 years;
- •Nasopharyngeal carcinoma;
- •Active autoimmune diseases;
- •HIV infected;
- •Required prednisone dose >=10mg daily;
- •Heart attack within 6 months;
- •Stroke within 6 months;
- •Other conditions that investigators consider the patients are not suitable for PD-1antibody;
研究组 & 干预措施
Arm A
Toripalimab 240mg IV, every 3 weeks;
干预措施: Toripalimab (Drug)
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
干预措施: Toripalimab (Drug)
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
干预措施: Paclitaxel (Drug)
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
干预措施: Carboplatin (Drug)
Arm C
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Cisplatin 25mg/m^2 IV,d1-d3, Q3W; 5-FU 3000mg/m^2 CIV 72h, Q3W
干预措施: Toripalimab (Drug)
Arm C
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Cisplatin 25mg/m^2 IV,d1-d3, Q3W; 5-FU 3000mg/m^2 CIV 72h, Q3W
干预措施: Paclitaxel (Drug)
Arm C
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Cisplatin 25mg/m^2 IV,d1-d3, Q3W; 5-FU 3000mg/m^2 CIV 72h, Q3W
干预措施: Cisplatin (Drug)
Arm C
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Cisplatin 25mg/m^2 IV,d1-d3, Q3W; 5-FU 3000mg/m^2 CIV 72h, Q3W
干预措施: 5-fu (Drug)
结局指标
主要结局
MPR
时间窗: 6 weeks
major pathologic response
次要结局
- RFS(2 years)
- PFS(6 months)
- AE(2 years)
- ORR(6 weeks)
研究者
Yulong Zheng
Principal Investigator
First Affiliated Hospital of Zhejiang University