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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Histologically confirmed nasopharyngeal carcinoma;

Expected survival time ≥12 weeks;

ECOG performance status: 0-1;

Disqualifiers

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;

Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Adjuvant therapy armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

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

Time frame
3 years

Secondary outcomes

1

Overall survival

The time from enrollment to death due to any cause or censored at the date of last follow-up.

Time frame
3 years
2

Toxicities

Adverse effects (AE) are evaluated by CTCAE 4.0

Time frame
3 years

Other outcomes

Sponsors and contacts

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