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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy
ClinicalTrials.gov ID: NCT07067268
What this study is testing
What is Adjuvant therapy?
Adjuvant therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for nasopharyngeal cancinoma (npc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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);
You likely can't join 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;
See the full eligibility criteria
- 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)...
- Signed informed consent with willingness to comply with the study protocol.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.