Actively Recruiting
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Led by National Cancer Centre, Singapore · Updated on 2026-04-14
53
Participants Needed
2
Research Sites
273 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
B
BeOne Medicines Singapore Pte. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and understand the study requirements
- Age 21 years or older at the time of consent
- Diagnosed with locoregionally-advanced nasopharyngeal carcinoma (AJCC/UICC 8th edition TNM-stage III-IVA)
- Detectable Epstein-Barr virus DNA levels after 3 cycles of induction chemotherapy
- ECOG Performance Status of 0 or 1
- Females of childbearing potential willing to use effective birth control during the study and for at least 120 days after last dose of tislelizumab, with a negative pregnancy test within 7 days before starting the trial
- Non-sterile males willing to use effective birth control during the study and for at least 120 days after last dose of tislelizumab
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other immune checkpoint modulators
- Previous radiotherapy or systemic anti-cancer therapy for nasopharyngeal carcinoma except induction chemotherapy completed within last 22 days; concurrent chemo-radiotherapy after induction chemotherapy allowed
- Known central nervous system metastases or carcinomatous meningitis
- Active autoimmune diseases or history of autoimmune diseases prone to relapse (except controlled conditions like Type I diabetes, hypothyroidism on hormone replacement, controlled celiac disease, or certain skin diseases)
- Any active malignancy within 2 years before study start except locally treated cancers with low relapse risk
- Recent use of systemic corticosteroids or immunosuppressive medication within 14 days before study start (with exceptions for certain steroid regimens)
- Uncontrolled diabetes or significant laboratory abnormalities despite treatment within 14 days before study start
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary diseases
- Severe or active infections requiring systemic therapy, recent severe infections or antibiotic use
- Known HIV infection
- Untreated chronic hepatitis B or hepatitis C infection with active viral load above specified limits
- Major surgery requiring general anesthesia within 28 days before study start
- Prior allogeneic stem cell or organ transplantation
- Significant cardiovascular risk factors or recent serious cardiac events
- Severe hypersensitivity to study drugs or their components
- Use of herbal medicines to control cancer within 14 days before study start
- Unrecovered toxicities from prior anticancer therapy except benign conditions
- Administration of live vaccines within 4 weeks before study start
- Medical conditions or substance abuse that could interfere with study participation
- Concurrent participation in another therapeutic clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
2
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
Research Team
M
Melvin LK CHUA, MBBS, FRCR, PhD, FAMS, FASCO
CONTACT
E
Enya HW ONG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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