Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma - Trial NCT06093061
Access comprehensive clinical trial information for NCT06093061 through Pure Global AI's free database. This Phase 2 trial is sponsored by National Cancer Centre, Singapore and is currently Not yet recruiting. The study focuses on Nasopharyngeal Carcinoma. Target enrollment is 69 participants.
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Study Focus
CCRT with Maintenance Tislelizumab and Metronomic Capecitabine
Interventional
combination product
Sponsor & Location
National Cancer Centre, Singapore
Timeline & Enrollment
Phase 2
Dec 01, 2023
Oct 01, 2029
Primary Outcome
2-year Disease-Free Survival (DFS) rate.
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06093061
Non-Device Trial