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.
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.
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;
Single group
Envafolimab and recombinant human endostatin combined with chemoradiotherapy
DrugInduction treatment phase: Envafolimab administered by subcutaneous injection on day 1 every 3 weeks at 300 mg for 3 cycles, cisplatin administered by intravenous infusion on day 1 of each cycle at 80 mg/m2 every 3 weeks for 3 cycles, gemcitabine was administered by intravenous infusion on days 1 and 8 of each cycle at 1 g/m2 every 3 weeks for 3 cycles, recombinant human endostatin was administered on day 1 every 3 weeks at 210 mg for 3 cycles. Concurrent treatment phase: Cisplatin was administered by intravenous infusion on day 1 of each cycle at 100mg/m2 every 3 weeks for 2 cycles. Adjuvant treatment Phase: Envafolimab was administered on day 1 every 3 weeks at 300 mg for 8 cycles as a subcutaneous injection. Intensity-modulated radiotherapy: 69.96Gy/33fractions/7 weeks,5 fractions/week, 1 fraction/day.
Complete Response Rate (CRR) after Induction Therapy
The proportion of patients in whom all target and non-target lesions confirmed at baseline have completely disappeared, as assessed by magnetic resonance imaging (MRI) following the completion of induction therapy.
Objective Response Rate (ORR) after Induction Therapy
The proportion of patients who achieve an objective reduction in tumor size after induction therapy, including those with complete response and partial response.
Progression Free Survival (PFS)
Defined as the time interval from randomization to tumor progression or death due to any cause. The appearance of new lesions was used as a criterion for progression, and the landmark time point of progression was the date when measurable new lesions were first observed.
Overall survival (OS)
Overall survival is measured from randomization until death due to any cause or the latest known date alive.
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time interval from randomization to the first occurrence of recurrence, or to the last follow-up time if there was no recurrence.
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