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NCT06093061

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

RIBBON-LA-01: Single-arm, Open-label, Phase 2 Trial of Tislelizumab and Metronomic Capecitabine as Maintenance Therapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
National Cancer Centre, Singapore·Phase 2·ClinicalTrials.gov·combination productNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Nasopharyngeal Carcinoma
Drug/Device/Intervention
CCRT with Maintenance Tislelizumab and Metronomic Capecitabine
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
National Cancer Centre, Singapore
Location
Singapore,Singapore, Singapore
Timeline & enrollment
Phase
Phase 2
Start date
Dec 01, 2023
End date
Oct 01, 2029
Enrollment
69 participants
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
Malignant neoplasm of nasopharynxMalignant neoplasm: Nasopharynx, unspecifiedMalignant neoplasm: Overlapping lesion of nasopharynxBenign neoplasm: NasopharynxMalignant neoplasm: Posterior wall of nasopharynx
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06093061
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.