Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

Patients with "high-risk" locoregionally-advanced nasopharyngeal carcinoma (LA-NPC), defined as AJCC/UICC 8th edition TNM-stage III-IVA and high Epstein-Barr virus (EBV) DNA viral load (≥4,000 copies/mL) will require induction chemotherapy (IC) prior to chemo-radiation (CCRT) as per standard treatment. Patients who persist to manifest DETECTABLE EBV DNA following 3 cycles of IC have a higher risk of relapse, and are typically recommended for a year of low-dose oral chemotherapy after CCRT. RIBBON-LA-01 is a single-arm, open-label, phase 2 clinical trial of maintenance tislelizumab and metrono

Trial Details

NCT ID
NCT06093061
Phase
PHASE2
Sponsor
National Cancer Centre, Singapore
Status
RECRUITING
Cancer Type
Nasopharyngeal Head and Neck Cancer
Interventions
  • CCRT with Maintenance Tislelizumab and Metronomic Capecitabine
Locations (sample)
  • Singapore, Singapore|1.28967,103.85007
  • Singapore, Singapore|1.28967,103.85007

Key Eligibility Criteria

  • Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
  • Age ≥21 years on the day of signing the ICF
  • LA-NPC defined as AJCC/UICC 8th edition TNM-stage III-IVA
  • DETECTABLE EBV DNA levels following 3 cycles of IC, defined as \>0 copies/mL

For full eligibility, visit ClinicalTrials.gov.

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