Clinical trial NCT06321939: Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma
Official title: Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Herpesvirus 4, Human
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-metastatic NPC

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.

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.

Primary outcomes:
measure: Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing
timeFrame: from diagnose to 4-8 weeks after definitive radiotherapy
Secondary outcomes:
measure: Overall survival
timeFrame: 2 year
measure: Distant metastasis failure-free survival
timeFrame: 2 year
measure: Locoregional failure-free survival
timeFrame: 2 year
measure: Failure-free survival
timeFrame: 2 year
measure: Patient reported quality-of-life score
timeFrame: up to 2 years
measure: Biomarker analysis
timeFrame: from diagnose to 4-8 weeks after definitive radiotherapy
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan cancer Hospital
state: Hunan
Study officials:
References: