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 metronomic capecitabine (metroCap) for 52 weeks after IC and CCRT, targeting this specific group of patients who have persistent detectable EBV DNA after IC. The main objective is to evaluate the efficacy of maintenance tislelizumab and metroCap in patients with DETECTABLE EBV DNA levels after 3 cycles of IC.

NCT Number	NCT06093061
Lead Sponsor	National Cancer Centre, Singapore Collaborators: BeOne Medicines Singapore Pte. Ltd., Tan Tock Seng Hospital
Conditions	Nasopharyngeal Carcinoma
Enrollment	53 participants
Start Date	2024-07-03
Primary Completion	2028-10 (estimated)
Study Completion	2029-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-14