Induction Chemotherapy and Toripalimab Followed by Surgery or Radiotherapy for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Laryngeal Preservation rate at 3-month post-radiotherapy
研究概览
简要总结
The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.
详细描述
Historically, induction chemotherapy could provide a chance of larynx preservation for approximate 60-70% of patients with locally advanced laryngeal/hypopharyngeal carcinoma. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma (T2-4a, N0-resectable N3, M0);
- •Age between 18-75 years;
- •Signed inform consent;
- •Had at least one measurable lesion according to RECIST 1.1 criteria
- •Anticipated overall survival more than 3 months;
- •Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
- •Normal organ function;
- •HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
- •Male and no pregnant female, able to adapt birth control methods during treatment.
排除标准
- •Hypersensitivity to Toripalimab, Paclitaxel, Nab-Paclitaxel and Cisplatin;
- •Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- •Severe, uncontrolled heart disease;
- •Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
- •Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
- •Surgery or trauma within 28 days prior to signing the informed consent;
- •Received other immune checkpoint inhibitors previously;
- •Severe, uncontrolled infections within 28 days of prior to signing the informed consent;
- •Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
- •History of interstitial lung disease;
- •HIV positive;
- •Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
- •Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
- •Women of child-bearing potential who are pregnant or breastfeeding.
研究组 & 干预措施
Induction chemotherapy and Toripalimab
Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2，Cisplatin 25mg/m2 d2-4 q3w.
Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If ORR of primary tumor is CR/PR, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 8 cycles (6 months). Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 8 cycles.
干预措施: chemotherapy TP regimen combined with Toripalimab (Drug)
结局指标
主要结局
Laryngeal Preservation rate at 3-month post-radiotherapy
时间窗: 3-month post-radiotherapy
defined as the absence of any residual disease that would justify salvage total laryngectomy
次要结局
- Major pathologic response rate of the patients receiving surgical resection(Within 3 weeks after surgery)
- Progression-free survival rate at 1 year(One year post-radiotherapy)
- Pathological complete response rate of the patients receiving surgical resection(Within 3 weeks after surgery)
- Laryngeal Preservation rate at 1 year(One year post-radiotherapy)
- Laryngeal Preservation rate at 2 year(Two year post-radiotherapy)
- Adverse Effect(One year post-radiotherapy)
- Overall response rate of induction therapy(2 weeks after the 3th cycle of induction therapy)
- Overall response rate of treatment(3 months post-radiotherapy)
- Overall survival rate at 1 year(One year post-radiotherapy)
- Overall survival rate at 2 year(Two year post-radiotherapy)
- Progression-free survival rate at 2 year(Two year post-radiotherapy)
研究者
Xiayun He, MD
M.D., professor
Fudan University