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

Last updated: March 14, 2024
Sponsor: Hunan Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

EBV-DNA next generation sequencing

Clinical Study ID

NCT06321939
NPCNS 001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Newly diagnosed, pathologically proven World Health Organization (WHO) type II/IIIuntreated NPC;
  2. Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC/UICC clinicalstaging 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 threecycles of induction chemotherapy (IC) (gemcitabine-cisplatin [GP] orpaclitaxel-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 contraceptivemeasures from screening to 1 year after treatment;
  9. Patients will be required to sign informed consent forms and be willing and able tocomply with the requirements for visits, treatment, laboratory tests, and otherresearch requirements stipulated in the research schedule.

Exclusion

Exclusion Criteria:

  1. Receiving surgery, target therapy, and/or immunotherapy during or before inductionphase;
  2. Other previous or concurrent malignant tumors, except adequately treated non-melanomaskin cancer, cervical carcinoma in situ, and thyroid papillary cancer;
  3. Pregnant or lactating women (a pregnancy test should be considered for fertile womenwith an active sex life);
  4. Previously treated with radical radiotherapy (RT), except non-melanoma skin cancersoutside 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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: EBV-DNA next generation sequencing
Phase:
Study Start date:
January 11, 2024
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Hunan cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

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