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Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07067268•Fudan University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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;
+5 more criteria

Locations (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, China, China

Key Dates

Start Date

September 14, 2024

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2029

Last Updated

July 16, 2025

Enrollment

ESTIMATED participants

Conditions

Nasopharyngeal Cancinoma (NPC)

Interventions

Adjuvant therapy

DRUG

Contacts

Hongmei Ying

CONTACT

+8602164175590-86703 yinghongmei2013@163.com

Fangfang Kong

CONTACT

+8613817283123 ago123.com@163.com

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

NCT07201337

Nasopharyngeal Cancinoma (NPC)

View study

RECRUITINGPHASE2

SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

NCT06676722

Nasopharyngeal Cancinoma (NPC)SBRT+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

GP Combined with Toripalimab Versus GP Induction Chemotherapy for Advanced Childhood Nasopharyngeal Carcinoma