NCT07067268 Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy
| NCT ID | NCT07067268 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Nasopharyngeal Cancinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-09-14 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2024-09-14 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07067268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasopharyngeal Cancinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07067268 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07067268 currently recruiting?
Yes, NCT07067268 is actively recruiting participants. Contact the research team at yinghongmei2013@163.com for enrollment information.
Where is the NCT07067268 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07067268 clinical trial?
NCT07067268 is sponsored by Fudan University. The trial plans to enroll 76 participants.