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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Newly diagnosed, pathologically proven World Health Organization (WHO) type II/IIIuntreated NPC;
- Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC/UICC clinicalstaging 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 threecycles of induction chemotherapy (IC) (gemcitabine-cisplatin [GP] orpaclitaxel-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 contraceptivemeasures from screening to 1 year after treatment;
- 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:
- Receiving surgery, target therapy, and/or immunotherapy during or before inductionphase;
- Other previous or concurrent malignant tumors, except adequately treated non-melanomaskin cancer, cervical carcinoma in situ, and thyroid papillary cancer;
- Pregnant or lactating women (a pregnancy test should be considered for fertile womenwith an active sex life);
- Previously treated with radical radiotherapy (RT), except non-melanoma skin cancersoutside 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.
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
Connect with a study center
Hunan cancer Hospital
Changsha, Hunan
ChinaActive - Recruiting

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