Actively Recruiting
Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
Led by Chongqing University Cancer Hospital · Updated on 2026-02-18
30
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status of 0 or 1
- Age between 18 and 65 years, male or non-pregnant female
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO type II or III)
- High-risk locally advanced stage III-IVA nasopharyngeal carcinoma (T4N+ or N2-3), or pretreatment EBV-DNA 54000 copies/ml, or grade 3 lymph node extra-envelope invasion
- Measurable lesions with MRI data of nasopharynx and neck before enrollment
- Willing to provide tumor tissue for PD-L1 testing
- Agree to EBV antibody and EBV-DNA testing before treatment
- Hematology: WBC 4000/bcL, neutrophils 2.000/bcL, hemoglobin 9 g/dL, platelets 100,000/bcL
- Liver function: ALT and AST less than 1.5 times upper limit of normal, total bilirubin less than 1.5 times upper limit
- Renal function: serum creatinine less than 1.5 times upper limit of normal
- Signed informed consent and able to comply with study procedures
You will not qualify if you...
- Recurrent nasopharyngeal carcinoma or distant metastasis
- Keratinizing squamous cell carcinoma (WHO type I)
- Previous radiotherapy or systemic chemotherapy
- Pregnant or lactating women without effective contraception
- HIV positive
- History of other malignancies except cured basal cell carcinoma or cervical carcinoma in situ
- Prior treatment with immune checkpoint inhibitors (CTLA-4, PD-1, PD-L1, etc.)
- Need for long-term immunosuppressive therapy or corticosteroids
- Immunodeficiency or history of organ transplantation
- Recent use of high-dose glucocorticoids within 4 weeks
- Laboratory values outside required ranges within 7 days before enrollment
- Significant dysfunction of heart, liver, lung, kidney, or bone marrow
- Contraindications to vascular endothelial inhibitors, chemoradiotherapy, or immunotherapy
- Recent arterial thrombosis or embolism within 6 months
- Severe uncontrolled medical illness or infection
- Concurrent use of other investigational drugs or participation in other trials
- Refusal or inability to sign informed consent
- Personality or mental disorders affecting capacity
- Positive hepatitis B surface antigen with high viral load
- Positive HCV antibody without negative HCV RNA test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
Research Team
X
Xin Zhang, Ph.D, M.D.
CONTACT
J
Jiang D Sui, Ph.D, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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