Tislelizumab plus capecitabine for nasopharyngeal cancer with leftover EBV DNA after radiation

A Multicenter, Randomized Controlled, Phase II Trail of Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA After Radiotherapy

This will test whether adding the immunotherapy tislelizumab to the oral chemotherapy capecitabine helps people with nasopharyngeal cancer who still have detectable EBV DNA after radiotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy
• Locations: 1 site (Shanghai, China)
• Trial ID: NCT07067268 on ClinicalTrials.gov

What this trial studies

This is a single-center, phase 2 interventional adjuvant trial enrolling adults with histologically confirmed nasopharyngeal carcinoma who have detectable plasma EBV DNA shortly before or after completing definitive radiotherapy. Enrolled patients with good performance status and adequate organ function will receive combined tislelizumab (a PD-1 inhibitor) and capecitabine with planned safety and efficacy follow-up. The primary focus is to determine whether the combination can clear residual viral DNA and reduce early recurrence while monitoring treatment-related toxicity. The trial is led by Fudan University Shanghai Cancer Centre and targets patients able to attend visits at that site.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with histologically confirmed nasopharyngeal carcinoma, detectable plasma EBV DNA within one week before to four weeks after radiotherapy, ECOG 0–1, expected survival ≥12 weeks, and adequate organ function who can consent and comply with visits.

Not a fit: Patients without detectable post-radiotherapy EBV DNA, those with poor performance status or inadequate organ function, or those unable to travel to the study site are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could lower recurrence risk and improve outcomes for patients with residual EBV DNA after radiotherapy.

How similar studies have performed: Immune checkpoint inhibitors have shown activity in recurrent or metastatic nasopharyngeal carcinoma and chemo–immunotherapy combinations have shown promise, but using tislelizumab plus capecitabine as adjuvant therapy for residual EBV DNA is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years;
2. Histologically confirmed nasopharyngeal carcinoma;
3. Expected survival time ≥12 weeks;
4. ECOG performance status: 0-1;
5. Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
6. Plasma EBV DNA \>0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;
7. Adequate organ function meeting the following criteria: Hematological: a. Hemoglobin (HB) ≥90 g/L; b. Absolute neutrophil count (ANC) ≥1.0×10⁹/L; c. Platelet count (PLT) ≥80×10⁹/L; Biochemical: a. Total bilirubin (BIL) \<1.5× upper limit of normal (ULN); b. ALT and AST \<2.5×ULN; c. Serum creatinine (Cr) ≤ULN, and creatinine clearance rate ≥50 mL/min (calculated by Cockcroft-Gault formula); d. Normal myocardial enzymes and thyroid function; e. Normal cardiac function assessed by echocardiography.
8. Signed informed consent with willingness to comply with the study protocol.

Exclusion Criteria:

1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)；
2. Distant metastasis detected by pre-treatment clinical or imaging examinations;
3. History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;
4. History of autoimmune diseases, except for the following conditions (eligible after evaluation):

   1. Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;
   2. Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;
5. Previous or concurrent malignancies (except those cured and disease-free for \>5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);
6. Positive pregnancy test in women of childbearing potential;
7. Concurrent medical conditions that may compromise patient enrollment or safety during the study;
8. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;
9. Active psychiatric disorders or other mental conditions affecting informed consent comprehension;
10. Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);
11. Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention;
12. Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion);
13. Unwillingness to sign informed consent.

Where this trial is running

Shanghai, China

• Fudan Universtiy Shanghai Cancer Centre — Shanghai, China, China (Recruiting)

Study contacts

• Study coordinator: Hongmei Ying

Conditions Nasopharyngeal Cancinoma; Nasopharyngeal Carcinoma; EBV DNA; Tislelizumab; capecitabine; Adjuvant therapy