About this trial
This is a single-center, prospective, single-arm, phase II clinical study, to evaluate the therapeutic efficacy and safety of envafolimab combined with chemoradiotherapy and recombinant human endostatin in patients with locally advanced nasopharyngeal carcinoma.
Eligibility criteria
Qualifiers
ECOG score 0-1.
Aged 18-65 years, male or non-pregnant female;
Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the need to detect MSI and dMMR status.
high-risk locally advanced stage III-IVA (8th AJCC/UICC staging), i.e., T4N+ or N2-3, or pretreatment EBV-DNA ≥4000 copies/ml, or lymph node extra-envelope invasion grade 3 (invasion of muscle skin, etc.), treatment-naive nasopharyngeal carcinoma patients.
Disqualifiers
Patients with recurrent nasopharyngeal carcinoma and distant metastasis.
Pathology was keratinizing squamous cell carcinoma (WHO classification type I).
Patients who have undergone radiotherapy or systemic chemotherapy;
Pregnant or lactating women, in the reproductive period without effective contraceptive measures;
Trial design
Treatments tested in this trial
- Envafolimab and recombinant human endostatin combined with chemoradiotherapy