PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Radiation

• Registration Number: NCT03989297
• Lead Sponsor: Kiang Wu Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NPC patients	Radiation	Consecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included.

Primary Outcome Measures

Name	Time	Method
Response rate	Followed up with 12 months after last patient in	Efficacy after radiation

Secondary Outcome Measures

Name	Time	Method
Survival rate	Followed up with 12 months after last patient in	Survival in PD-L1 positive and negative group

Trial Locations

Locations (1)

Kiang Wu Hospital; 🇨🇳 Macao, China