Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Nasopharyngeal Cancinoma (NPC)

Treatments: Drug: Adjuvant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07067268

BioNPC-03

Details and patient eligibility

About

This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

76 participants in 2 patient groups

Adjuvant therapy arm

Experimental group

Description:

Tislelizumab combined with capecitabine therapy

Treatment:

Drug: Adjuvant therapy

Control arm

No Intervention group

Description:

Clinical follow-up and surveillance only