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

NCT ID: NCT07067268

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-14
• Study Completion Date: 2029-12-31

Brief Summary

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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant therapy arm

Tislelizumab combined with capecitabine therapy

Group Type: EXPERIMENTAL

Adjuvant therapy

Intervention Type: DRUG

Tislelizumab: 200 mg IV on day 1, every 3 weeks Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks Treatment duration: 8 cycles

Control arm

Clinical follow-up and surveillance only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adjuvant therapy

Tislelizumab: 200 mg IV on day 1, every 3 weeks Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks Treatment duration: 8 cycles

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Chaosu Hu

Professor, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan Universtiy Shanghai Cancer Centre

Shanghai, China, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongmei Ying

Role: CONTACT

yinghongmei2013@163.com

+8602164175590-86703

Fangfang Kong

Role: CONTACT

ago123.com@163.com

+8613817283123

Facility Contacts

Hongmei Ying, M.D.

Role: primary

yinghongmei2013@163.com

+8602164175590 ext. 86703

Other Identifiers

BioNPC-03

Identifier Type: -

Identifier Source: org_study_id