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

NCT07067268 | Recruiting Phase 2

• 1 other identifier: BioNPC-03
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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)

Keywords

Nasopharyngeal Carcinoma; EBV DNA; Tislelizumab; capecitabine; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Defined from date of randomization to date of first documentation of progression or death due to any cause

  3 years

Secondary Outcomes (2)

• Overall survival

  3 years

• Toxicities

  3 years

Study Arms (2)

Adjuvant therapy arm

EXPERIMENTAL

Tislelizumab combined with capecitabine therapy

Drug: Adjuvant therapy

Control arm

NO INTERVENTION

Clinical follow-up and surveillance only

Interventions

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

Adjuvant therapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Histologically confirmed nasopharyngeal carcinoma;
• Expected survival time ≥12 weeks;
• ECOG performance status: 0-1;
• Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
• Plasma EBV DNA \>0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;
• 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.
• Signed informed consent with willingness to comply with the study protocol.

You may not qualify if:

• 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):
• Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;
• Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, China, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Central Study Contacts

Hongmei Ying

CONTACT

+8602164175590-86703; yinghongmei2013@163.com

Fangfang Kong

CONTACT

+8613817283123; ago123.com@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D.

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: September 14, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CN (1)