RecruitingPhase 2NCT06059261

Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.

A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin in Locally Advanced Nasopharyngeal Carcinoma.

Sponsor

Chongqing University Cancer Hospital

Enrollment

30 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of immunotherapy (envafolimab), standard chemoradiotherapy, and a drug that blocks new blood vessel growth (recombinant human endostatin) for patients with locally advanced nasopharyngeal carcinoma, a type of head and neck cancer. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with a specific type of nasopharyngeal carcinoma (non-keratinizing, WHO type II or III) - Your cancer is at a high-risk locally advanced stage (Stage III-IVA) and has not been previously treated - Your general health is good (ECOG score 0-1) **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond what is allowed - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnvafolimab and recombinant human endostatin combined with chemoradiotherapy

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.

Locations(1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

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NCT06059261

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