Counting Epstein-Barr Virus DNA in Blood for Nasopharyngeal Carcinoma Patients

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

This study is testing a new blood test to see if counting Epstein-Barr Virus DNA can help doctors better monitor treatment responses in patients with nasopharyngeal carcinoma.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hunan Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06321939 on ClinicalTrials.gov

What this trial studies

This study investigates a new method for monitoring Epstein-Barr Virus (EBV) DNA levels in the blood of patients with non-metastatic nasopharyngeal carcinoma (NPC) using next generation sequencing (NGS). Patients will have their plasma EBV DNA counted at diagnosis, after two cycles of induction chemotherapy, and 4-8 weeks post-radiotherapy. The goal is to determine if this sequencing-based approach offers better sensitivity and specificity compared to traditional PCR analysis, ultimately aiding in treatment response monitoring and personalized treatment strategies.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with newly diagnosed, non-metastatic, pathologically confirmed nasopharyngeal carcinoma.

Not a fit: Patients with metastatic nasopharyngeal carcinoma or those with significant comorbidities affecting treatment eligibility may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could lead to more accurate monitoring of treatment responses in NPC patients, allowing for tailored therapeutic approaches.

How similar studies have performed: While the use of NGS for EBV DNA monitoring is a novel approach, previous studies have shown promise in using similar methodologies for other cancers.

Eligibility criteria

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.

Where this trial is running

Changsha, Hunan

• Hunan cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Yaqian Han

Conditions Nasopharyngeal Carcinoma; Herpesvirus 4, Human