NCT04399785Unknown2 期
Phase II Study for Combination of Camrelizumab and Stereotacic Radiotherapy in the First-line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Xingchen Peng1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study is a prospective, single-center, open-label, phase II clinical study for patients with recurrent or metastatics quamous cell carcinoma of the head and neck.
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
- •Histologically confirmed squamous cell carcinoma of the head and neck;
- •Patients with untreated recurrent or metastatic disease;
- •Combined positive Score>=1;
- •Aged >=18 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •At least one measurable lesion, according to RECIST 1.1;
- •Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion):
- •HB>=80g/L, ANC>=1.5x10^9/L, PLT >=80x10^9/L;
- •TBIL<=1.5 ULN, ALT and AST <=2.5 ULN, if there exists hepatic metastases, ALT and AST <=5 ULN, Cr <=1.5 ULN or CCr >=60ml/min;
- •INR or PT <= 1.5 ULN, APTT <=1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range);
- •BNP <=ULN;
- •T3 <=ULN and T4 <=ULN after treatment;
- •Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment; For female subjects with reproductive potential: a negative serum pregnancy test;
- •Have signed consent form.
排除标准
- •Have other malignant tumors in the past 5 years, except for cured in cured basal cell carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ;
- •Known allergic reactions to the components of PD-1 monoclonal antibody;
- •Central nervous system metastasis with symptoms;
- •Treatment with a strong CYP3A4 inhibitor within 1 week or a strong inducer of CYP3A4 within 2 weeks.
- •Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
- •Ischemic cardiovascular events occurred within 1 year prior to the start of treatment;
- •ECG QT interval >500ms;
- •Patients are receiving immunosuppressive therapy;
- •Treatment with an immunotherapy, including anti-PD-1, anti-PD-L1 and anti-CTLA-4;
- •Treatment with an investigational agent within 4 weeks;
- •Treatment with oral or parenteral corticosteroids (>10mg per day) within 2 weeks or a requirement for chronic systemic immunosuppressive therapy;
- •Treatment with anti-tumor vaccine or live vaccines within 4 weeks
- •Surgery or severe trauma within 4 weeks;
- •Active infection;
- •Active autoimmune disease;
- •History of immunodeficiency, including HIV antibody positive, primary immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- •History of noninfectious pneumonia;
- •Active tuberculosis within 1 year, or had a history of active tuberculosis infection one year ago but did not receive standard treatment;
- •Active hepatitis, including HBV DNA ≥ 2000IU/ml or 10 ⁴ copies / ml or HCV antibody and HCV-RNA positive;
- •History of alcoholism and drug abuse;
- •Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
- •Patients are pregnant or breast-feeding;
- •Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
结局指标
主要结局
ORR
时间窗: up to approximately 2 years
Objective Response Rate
次要结局
- OS(up to approximately 2 years)
- PFS(up to approximately 2 years)
- DOR(up to approximately 2 years)
- AE(from the first drug administration to within 30 days for the last therapy)
研究者
Xingchen Peng
Associate professor
West China Hospital
研究点 (1)
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