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.
This is a single-center, prospective, single-arm phase II clinical study. Patients with high-risk locally advanced stage III-IVA (8th AJCC/UICC staging) primary nasopharyngeal carcinoma, 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.) are enrolled. After being screened to meet the enrolment criteria and signing the informed consent form, they will receive 3 cycles of induction therapy with envafolimab combined with recombinant human vascular endothelial inhibitor and gemcitabine and cisplatin, followed by cisplatin-concomitant radiotherapy, and 8 cycles of adjuvant therapy with envafolimab after radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Induction 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.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGComplete 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.
Time frame: From enrollment to the end of induction therapy at 12 weeks
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.
Time frame: From enrollment to the end of induction therapy at 12 weeks
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.
Time frame: 2 years
Overall survival (OS)
Overall survival is measured from randomization until death due to any cause or the latest known date alive.
Time frame: 2 years
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.
Time frame: 2 years
Distant metastases-Free survival (DMFS)
Defined as the time interval from randomization to the occurrence of distant metastasis after treatment, or the time to the last follow-up or death due to other causes if there was no distant metastasis.
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Time frame: 2 years
Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs, according to the Common Terminology Criteria for Adverse Events, version 5.0.
Time frame: through study completion, an average of 1 year