Skip to main content
Clinical Trials/ISRCTN10570964
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)

Registry
who.int
Start Date
April 29, 2021
End Date
December 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Merck Sharp and Dohme (China)

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

Similar Trials