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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321939
• Other study ID #: NPCNS 001
• Status: Recruiting
• Start date: January 11, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Hunan Cancer Hospital
• Contact: Yaqian Han
• Phone: (+86)18673176667
• Email: hanyaqian[@]hnca.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Epstein-Barr Virus Infections
• Herpesvirus 4, Human
• Nasopharyngeal Carcinoma

Intervention

Diagnostic Test:
• EBV-DNA next generation sequencing
EBV-DNA next generation sequencing

Locations

Country	Name	City	State
China	Hunan cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing	Plasma EBV DNA analysis by NGS on enrollment, after 2 cycles of induction chemotherapy, and 4-8 weeks after definitive radiotherapy.	from diagnose to 4-8 weeks after definitive radiotherapy
Secondary	Overall survival	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.	2 year
Secondary	Distant metastasis failure-free survival	Measured from the day of enrollment until death until distant metastasis , or the last follow-up visit.	2 year
Secondary	Locoregional failure-free survival	Measured from the day of enrollment until death until local and/or regional recurrence, or the last follow-up visit.	2 year
Secondary	Failure-free survival	Measured from the day of enrollment until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.	2 year
Secondary	Patient reported quality-of-life score	Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30).	up to 2 years
Secondary	Biomarker analysis	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.	from diagnose to 4-8 weeks after definitive radiotherapy