NCT06321939 Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma
| NCT ID | NCT06321939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hunan Cancer Hospital |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-01-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06321939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321939 currently recruiting?
Yes, NCT06321939 is actively recruiting participants. Contact the research team at hanyaqian@hnca.org.cn for enrollment information.
Where is the NCT06321939 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06321939 clinical trial?
NCT06321939 is sponsored by Hunan Cancer Hospital. The trial plans to enroll 50 participants.