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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant therapy arm | Experimental | Tislelizumab combined with capecitabine therapy |
|
| Control arm | No Intervention | Clinical follow-up and surveillance only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant therapy | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Defined from date of randomization to date of first documentation of progression or death due to any cause | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from enrollment to death due to any cause or censored at the date of last follow-up. | 3 years |
| Toxicities | Adverse effects (AE) are evaluated by CTCAE 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
Histologically confirmed keratinizing squamous cell carcinoma (WHO I);
Distant metastasis detected by pre-treatment clinical or imaging examinations;
History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;
History of autoimmune diseases, except for the following conditions (eligible after evaluation):
Previous or concurrent malignancies (except those cured and disease-free for >5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);
Positive pregnancy test in women of childbearing potential;
Concurrent medical conditions that may compromise patient enrollment or safety during the study;
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;
Active psychiatric disorders or other mental conditions affecting informed consent comprehension;
Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);
Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention;
Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion);
Unwillingness to sign informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongmei Ying | Contact | +8602164175590-86703 | yinghongmei2013@163.com | |
| Fangfang Kong | Contact | +8613817283123 | ago123.com@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Centre | Recruiting | Shanghai | China | 200032 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| 3 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |