KCT0003333
进行中（未招募）
未知
Window of Opportunity Trial of durvalumab (MEDI4736) or durvalumab/tremelimumab as neoadjuvant chemotherapy to identify immune dynamics in surgically resectable head and neck cancer patients
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Yonsei University Health System, Severance Hospital
- 入组人数
- 48
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Histologically confirmed stage II\-IV operable HNSCC oral cavity, hypopharynx, oropharynx, larynx
- •Measurable disease defined as lesions that can be accurately measured by RECIST 1\.1\.
- •Written informed consent and any locally\-required authorization obtained from the patient prior to performing any protocol\-related procedures, including screening evaluations
- •Age \>18 years at time of study entry or Adult male or female
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Body weight \>30kg
- •Life expectancy of at least 12 weeks
- •Adequate normal organ and marrow function as defined below:
- •o Haemoglobin \=9\.0 g/dL
- •oAbsolute neutrophil count (ANC) \> 1500 per mm3
排除标准
- •?Involvement in the planning and/or conduct of the study
- •?Participation in another clinical study with an investigational product during the last
- •?Concurrent enrolment in another clinical study, unless it is an observational (non\-interventional) clinical study or during the follow\-up period of an interventional study
- •?Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non–cancer\-related conditions (e.g., hormone replacement therapy) is acceptable.
- •?Any unresolved toxicity NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade \=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •oPatients with Grade \=2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician.
- •oPatients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
- •?History of allogenic organ transplantation.
- •?Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease], diverticulitis \[with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- •?Patients with vitiligo or alopecia
结局指标
主要结局
未指定
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