High-risk locally advanced nasopharyngeal cancer
Conditions
Interventions
Experimental group:Srulizumab and Nimotuzumab Combined with Chemoradiotherapy
Control group:Serplulimab (anti-PD-1) combined with chemoradiotherapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and <= 65 years; 2. The subject can understand the procedures and methods of this clinical study, has given full informed consent, and voluntarily signed the informed consent form; 3. Confirmed by pathological histology or cytology, the MRI images meet the AJCC/UICC clinical staging criteria (8th edition) for locally advanced nasopharyngeal carcinoma and the stage is cT3N2-3, cT4N0-3; 4. No any systemic anti-tumor treatment (targeted, immunological and/or chemotherapy) has been received; 5. ECOG PS score 0-1; 6. Tumor tissue (from the tumor tissue center or resected tumor tissue) can be provided for PD-L1 testing (if previously tested, no additional testing is required); 7. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion; 8. Hematological indicators meet the clinical study standards; 9. For female patients, a negative urine pregnancy test must be obtained before the study begins (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients).
Exclusion criteria
Exclusion criteria: 1.Prior to screening, received any systemic anti-tumor therapy including but not limited to: PD-1 inhibitors, EGFR-TKIs, EGFR monoclonal antibodies, anti-angiogenic agents, or chemotherapy; 2.Participation in any interventional clinical trial within 30 days prior to screening; 3.History of other malignant tumors (except cured basal cell carcinoma of the skin); 4.Presence of distant metastases confirmed by imaging; 5.Presence of severe uncontrolled comorbidities (e.g., heart failure, diabetes mellitus, hypertension, hepatic/renal insufficiency, thyroid disorders, or psychiatric illnesses); 6.Known infection with HIV, active viral hepatitis, or tuberculosis; 7.Major surgery within 30 days prior to first dose of investigational drug or planned surgery during the study period; 8.Systemic or local corticosteroid therapy within 4 weeks prior to enrollment; 9.Hypersensitivity to any component of the investigational drug(s) in this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety evaluation;Locoregional recurrence?free survival rate;Distant metastasis-free survival rate; | — |
Countries
China
Contacts
Public ContactHua yonghong
Zhejiang Cancer Hospital
Outcome results
None listed