NCT05862168招募中2 期
Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective，Phase II Study
Weijia Fang, MD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological Complete Response
研究概览
简要总结
TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell 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
- •Signed the informed consent form
- •Histopathological diagnosis of oral squamous cell carcinoma
- •Age: 18-75 years old , Gender: male and female
- •Primary tumor with a clinical stage of III/IVb (T1-2N+M0 或 T3-4N0-3M0, AJCC2018)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
- •No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors, VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.);
- •Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- •Adequte organ function based on laboratory test values obtained during the screening period：1）Blood routine: white blood cells (WBCs) >3.0× 109/L, ANC >1.5× 109/L, platelets >75× 109/L, hemoglobin >9 g/L, 2）Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal，3）Renal function: Serum creatinine <1.5 times the upper limit of normal，4）Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal，5）Left ventricular ejection fraction (LVEF) ≥ 50%
- •contraception
排除标准
- •Known history of malignancy, unless been cured and no recurrence for 5 years
- •Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
- •Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
- •Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.
- •Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
- •Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.
- •Serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose.
- •Known human immunodeficiency virus (HIV) infection
- •Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection).
- •History of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis.
- •Known allergic reaction to any ingredients or excipients of the therapy
- •Participation in other clinical trials within 30 days before enrollment
- •Pregnant or lactating women
- •Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial
研究组 & 干预措施
Treatment
Experimental
干预措施: Tislelizumab (Drug)
Treatment
Experimental
干预措施: Albumin paclitaxel (Drug)
Treatment
Experimental
干预措施: Cisplatin (Drug)
Treatment
Experimental
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Pathological Complete Response
时间窗: 6 months
次要结局
- Major pathologic response(6 months)
- Event-free survival(2 years)
- Disease-free survival(5 years)
- Overall survival(5 years)
研究者
Weijia Fang, MD
Oncology Department director
Zhejiang University
研究点 (1)
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