PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989297
• Other study ID #: KWH201701
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2020
• Source: Kiang Wu Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prognostic value of programmed death-ligand 1 (PD-L1) and BRAF expression in nasopharyngeal carcinoma (NPC) is not well-defined. In this study the investigators investigated alterations in PD-L1, BRAF and EGFR by using immunohistochemistry analysis in a cohort of consecutively enrolled NPC patients.

Description:

NPC is a common type cancer in Macau and Southern China. The role of PD-L1 in NPC remains controversial. There many reasons behind these inconsistent findings. We used the SP263 antibody with the standard cut off value of 1% and 5%, which is frequently used for lung cancer and other cancer types. We also plan to include over 150 patients, which will be the largest study in NPC. This will help us to gain insights in NPC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years of age

• Locally advanced (stage IIIB) or metastatic (stage IV) NPC

• Fresh-frozen tissue samples were available were included

• After treatment with curative surgery or radiotherapy in Macau

• With follow up data were available

Exclusion Criteria:

• Enrolment in studies that prohibit any participation in this observational study

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Radiation
Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.

Locations

Country	Name	City	State
China	Kiang Wu Hospital	Macao

Sponsors (1)

Lead Sponsor	Collaborator
Kiang Wu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Efficacy after radiation	Followed up with 12 months after last patient in
Secondary	Survival rate	Survival in PD-L1 positive and negative group	Followed up with 12 months after last patient in