Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a non-randomized phase 1, open-labeled clinical study, 1-arm, single center, to observe efficacy and safety of chemotherapy plus PD-L1 antibody Toripalimab every 21 days for 2 cycles as induction regimen in locoregionally-advanced laryngo-hypopharyngeal squamous cell cancer patients.
详细描述
Locoregionally advanced laryngo-hypopharyngeal squamous cell cancer patients have the demand of laryngo-preservation. Induction chemotherapy (FP) combined with Toripalimab (a humanized IgG4 monoclonal antibody against PD-1) will be given. This regimen will be given every 21 days for 2 cycles. Radiological examinations and PET(FDG/FAPI) examinations pre/post-treatment will be administrated for response evaluation.
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
- •Male/female patients aged≥18 years.
- •Histologically confirmed Laryngo-hypopharyngeal squamous cell cancer, previously untreated (including surgery/radiotherapy/chemotherapy/immunotherapy).
- •Locoregionally-advanced disease stage cT2-4N0-3M
- •ECOG performance status 0 to
- •Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- •HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
- •Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
- •Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.
排除标准
- •Pregnancy or children bearing potential.
- •Metastasis.
- •Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer
- •Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 6 months;
- •With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
- •With uncontrollable complications
- •Inadequate organ function
- •known hypersensitivity reaction to any of the study drugs or components.
- •Other unsuitable conditions determined by investigators.
研究组 & 干预措施
Experimental
5-Fluorouracil(750 mg/m2/d, CIV d1-5) Cisplatin(75mg/m2,d1)/Carboplatin(AUC5, d1) Toripalimab 240mg d1
干预措施: 5-Fluorouracil, Cisplatin, Toripalimab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 36 months
次要结局
- Safety: adverse events as assessed by CTCAE v5.(36 months)
- Progression free survival rate at 12 months(12 months)
- Duration of response(36 months)
- Laryngo-preservation rate at 12 months(12 months)
- Overall survival rate at 24 months(24 months)
研究者
Jun Zhang
Chair of Department of Oncology
Ruijin Hospital