OncoMatch/Clinical Trials/NCT06093061
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Is NCT06093061 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies CCRT with Maintenance Tislelizumab and Metronomic Capecitabine for nasopharyngeal carcinoma.
Treatment: CCRT with Maintenance Tislelizumab and Metronomic Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: EBV detectable dna (>0 copies/ml)
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
Cannot have received: radiotherapy or systemic anti-cancer therapy for NPC
Exception: induction chemotherapy (Cisplatin and Gemcitabine) completed within the last 22 days; concurrent chemo-radiotherapy (cisplatin with radiotherapy) following induction chemotherapy is allowed
Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC, except for induction chemotherapy (Cisplatin and Gemcitabine) that was completed within the last 22 days. Subjects who have started on concurrent chemo-radiotherapy (CCRT; cisplatin with radiotherapy) following completion of induction chemotherapy (Cisplatin with Gemcitabine) are allowed to enroll
Cannot have received: allogeneic stem cell transplantation or organ transplantation
Prior allogeneic stem cell transplantation or organ transplantation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06093061 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy, radiotherapy or systemic anti-cancer therapy for NPC, allogeneic stem cell transplantation or organ transplantation disqualifies patients from enrollment.
Does this trial require EBV?
Yes, EBV detectable dna is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IVA is required.
Is there an age limit?
Yes. Patients must be 99 years or younger and at least 21 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages