Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
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.
Timeline
- Start
- 2024-07-03
- Primary completion
- 2028-10
- Completion
- 2029-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 650 mg/m2 | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |