ISRCTN10570964已完成未知
A multi-center retrospective observational study to evaluate PD-L1 protein expression in Chinese patients with advanced esophageal cancers and head and neck squamous cell carcinoma
Merck Sharp and Dohme (China)0 个研究点目标入组 920 人开始时间: 2021年4月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 920
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37968103/ (added 16/11/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •General criteria:
- •1. Patient must have informed consent form (ICF) signed previously, which gives consent for his/her sample to be used in a future study, unless the patient is under conditions accepted by IRB/ERC to waive ICF. Otherwise, the patient must provide a specific written informed consent for this study
- •2. Patient is 18 years of age or older at diagnosis
- •Criteria for EC:
- •1. Patient has histologically or cytologically confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ (defined as adenocarcinomas of the lower esophagus with the center located within 1 cm to 5 cm above the anatomic EGJ)
- •2. Patient has metastatic disease or locally advanced, unresectable disease
- •3. Patient must have an available FFPE tumor specimen obtained with resection, core needle biopsy or endoscopic biopsy
- •3.1. Newly-obtained specimen (collected up to 6 weeks prior to the start of PD-L1 IHC test) is preferred to archived one
- •3.2. Archival tissue block should be no older than 1 year
- •3.3. Tumor specimen collected from the primary site is preferred to that from the metastatic site
- •Criteria for HNSCC:
- •1. Patient has histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC that is considered incurable by local therapies. The patient may not have a primary tumor site of nasopharynx (any histology)
- •2. Patient must have an available FFPE tumor specimen obtained with core or excisional biopsy
- •2.1. Newly-obtained biopsy specimen (within 90 days prior to start of PD-L1 IHC test) is preferred to an archived one
- •2.2. Archival tissue block should be no older than 2 years
- •2.3. Tumor specimen collected from the primary site is preferred to that from the metastatic site
- •2.4. Decalcified bony specimen is not accepted
排除标准
- •Patient has only a specimen obtained with fine needle aspirate (FNA) or cytologic specimen
研究者
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