Observational study to evaluate PD-L1 protein expression in Chinese patients with advanced esophageal cancers and head and neck squamous cell carcinoma

Not Applicable

Completed

• Conditions: Esophageal cancer and head and neck squamous cell carcinoma; Cancer

• Registration Number: ISRCTN10570964
• Lead Sponsor: Merck Sharp and Dohme (China)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37968103/ (added 16/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-29
• Study Completion: 2022-12-30
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 920

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

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

Exclusion Criteria

Patient has only a specimen obtained with fine needle aspirate (FNA) or cytologic specimen

Study & Design

• Study Type: Observational
• Study Design: Not specified