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临床试验/NCT06321939
NCT06321939招募中不适用

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

Hunan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed, pathologically proven World Health Organization (WHO) type II/III untreated NPC;
  • Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC/UICC clinical staging system);
  • Age at diagnosis: over 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1
  • Receiving recommended curative intention treatments:definitive radiotherapy w/wo three cycles of induction chemotherapy (IC) (gemcitabine-cisplatin [GP] or paclitaxel-cisplatin [TP] regimen);
  • 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;
  • 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;
  • Female subjects capable of becoming pregnant agree to use reliable contraceptive measures from screening to 1 year after treatment;
  • 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.

排除标准

  • Receiving surgery, target therapy, and/or immunotherapy during or before induction phase;
  • Other previous or concurrent malignant tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary cancer;
  • Pregnant or lactating women (a pregnancy test should be considered for fertile women with an active sex life);
  • Previously treated with radical radiotherapy (RT), except non-melanoma skin cancers outside intended RT treatment volume;
  • 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.

结局指标

主要结局

Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing

时间窗: from diagnose to 4-8 weeks after definitive radiotherapy

Plasma EBV DNA analysis by NGS on enrollment, after 2 cycles of induction chemotherapy, and 4-8 weeks after definitive radiotherapy.

次要结局

  • Overall survival(2 year)
  • Failure-free survival(2 year)
  • Biomarker analysis(from diagnose to 4-8 weeks after definitive radiotherapy)
  • Distant metastasis failure-free survival(2 year)
  • Patient reported quality-of-life score(up to 2 years)
  • Locoregional failure-free survival(2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yaqian Han

Professor

Hunan Cancer Hospital

研究点 (1)

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