Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 9:11 AM
Study NCT ID:
NCT07067268
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-05', 'studyFirstSubmitDate': '2025-07-05', 'studyFirstSubmitQcDate': '2025-07-05', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'Defined from date of randomization to date of first documentation of progression or death due to any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'The time from enrollment to death due to any cause or censored at the date of last follow-up.'}, {'measure': 'Toxicities', 'timeFrame': '3 years', 'description': 'Adverse effects (AE) are evaluated by CTCAE 4.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'EBV DNA', 'Tislelizumab', 'capecitabine', 'Adjuvant therapy'], 'conditions': ['Nasopharyngeal Cancinoma (NPC)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically confirmed nasopharyngeal carcinoma;\n3. Expected survival time ≥12 weeks;\n4. ECOG performance status: 0-1;\n5. Received definitive radiotherapy (± induction and/or concurrent chemotherapy);\n6. Plasma EBV DNA \\>0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;\n7. 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.\n8. Signed informed consent with willingness to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)；\n2. Distant metastasis detected by pre-treatment clinical or imaging examinations;\n3. History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;\n4. History of autoimmune diseases, except for the following conditions (eligible after evaluation):\n\n 1. Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;\n 2. Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;\n5. Previous or concurrent malignancies (except those cured and disease-free for \\>5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);\n6. Positive pregnancy test in women of childbearing potential;\n7. Concurrent medical conditions that may compromise patient enrollment or safety during the study;\n8. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;\n9. Active psychiatric disorders or other mental conditions affecting informed consent comprehension;\n10. Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);\n11. Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention;\n12. Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion);\n13. Unwillingness to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT07067268', 'briefTitle': 'Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BioNPC-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant therapy arm', 'description': 'Tislelizumab combined with capecitabine therapy', 'interventionNames': ['Drug: Adjuvant therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Clinical follow-up and surveillance only'}], 'interventions': [{'name': 'Adjuvant therapy', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Adjuvant therapy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongmei Ying, M.D.', 'role': 'CONTACT', 'email': 'yinghongmei2013@163.com', 'phone': '+8602164175590', 'phoneExt': '86703'}], 'facility': 'Fudan Universtiy Shanghai Cancer Centre', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongmei Ying', 'role': 'CONTACT', 'email': 'yinghongmei2013@163.com', 'phone': '+8602164175590-86703'}, {'name': 'Fangfang Kong', 'role': 'CONTACT', 'email': 'ago123.com@163.com', 'phone': '+8613817283123'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, M.D.', 'investigatorFullName': 'Chaosu Hu', 'investigatorAffiliation': 'Fudan University'}}}}