ISRCTN10570964
Completed
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 sites920 target enrollmentApril 29, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Esophageal cancer and head and neck squamous cell carcinoma
- Sponsor
- Merck Sharp and Dohme (China)
- Enrollment
- 920
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37968103/ (added 16/11/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Patient has only a specimen obtained with fine needle aspirate (FNA) or cytologic specimen
Outcomes
Primary Outcomes
Not specified
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