Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma

Recruiting

• Conditions: Herpesvirus 4, Human; Nasopharyngeal Carcinoma

• Registration Number: NCT06321939
• Lead Sponsor: Hunan Cancer Hospital

Brief Summary

The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.

Detailed Description

The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.

Study Timeline

• Study Start: 2024-01-11
• Study First Submitted: 2024-02-24
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Newly diagnosed, pathologically proven World Health Organization (WHO) type II/III untreated NPC;
2. Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC/UICC clinical staging system);
3. Age at diagnosis: over 18 years old;
4. Eastern Cooperative Oncology Group (ECOG) score: 0-1
5. Receiving recommended curative intention treatments：definitive radiotherapy w/wo three cycles of induction chemotherapy (IC) (gemcitabine-cisplatin [GP] or paclitaxel-cisplatin [TP] regimen);
6. Pre-treatment and post-IC1 cell-free Epstein-Barr virus (cfEBV) DNA > 0 copy/mL; systemic cfEBV DNA monitoring during IC phase for risk stratification;
7. Normal hematic, liver, and kidney function: hemoglobin (HG) > 90 g/L; neutrophil > 1.5 × 109/L; platelet > 100 × 109/L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance (Ccr) ≥ 60 mL/min;
8. Female subjects capable of becoming pregnant agree to use reliable contraceptive measures from screening to 1 year after treatment;
9. Patients will be required to sign informed consent forms and be willing and able to comply with the requirements for visits, treatment, laboratory tests, and other research requirements stipulated in the research schedule.

Exclusion Criteria

1. Receiving surgery, target therapy, and/or immunotherapy during or before induction phase;
2. Other previous or concurrent malignant tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary cancer;
3. Pregnant or lactating women (a pregnancy test should be considered for fertile women with an active sex life);
4. Previously treated with radical radiotherapy (RT), except non-melanoma skin cancers outside intended RT treatment volume;
5. Uncontrolled heart disease, e.g.: 1) Heart failure, New York Heart Association (NYHA) level ≥ 2; 2) unstable angina; 3) myocardial infarction in the past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing	from diagnose to 4-8 weeks after definitive radiotherapy	Plasma EBV DNA analysis by NGS on enrollment, after 2 cycles of induction chemotherapy, and 4-8 weeks after definitive radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 year	Measured from the day of enrollment until death due to any cause, or the last follow-upmeasured from the day of enrollment until death due to any cause, or the last follow-up visit.
Failure-free survival	2 year	Measured from the day of enrollment until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.
Biomarker analysis	from diagnose to 4-8 weeks after definitive radiotherapy	Exploratory biomarker analysis that would be able to predict patient treatment benefits, for example PD-L1 expression, antigen (other than EBV, eg. human cytomegalovirus(human cytomegalovirus \[HCMV\], TTV) DNA counting.
Distant metastasis failure-free survival	2 year	Measured from the day of enrollment until death until distant metastasis , or the last follow-up visit.
Patient reported quality-of-life score	up to 2 years	Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
Locoregional failure-free survival	2 year	Measured from the day of enrollment until death until local and/or regional recurrence, or the last follow-up visit.

Trial Locations

Locations (1)

Hunan cancer Hospital; 🇨🇳 Changsha, Hunan, China