Head & Neck Cancer, Radiotherapy
Conditions
Brief summary
This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous cell carcinoma (HNSCC) who are unfit for standard concurrent cisplatin-based chemoradiotherapy. Eligible patients will receive standard-dose intensity-modulated radiotherapy together with weekly nimotuzumab. The primary endpoint is 1-year overall survival rate. Secondary endpoints include progression-free survival, objective tumor response rate, locoregional control rate, distant metastasis rate, and treatment-related adverse events. Patients will be followed up for survival, tumor status and safety assessments after treatment completion.
Interventions
DRUGNimotuzumab
Humanized anti-EGFR monoclonal antibody, administered by intravenous infusion once weekly during the whole radiotherapy period.
Sponsors
Ke Hu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 65 years old. 2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx). 3. Positive EGFR test result in tumor tissue. 4. Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available. 5. ECOG performance status 0-2 OR KPS score ≥ 60. 6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy. 7. At least one measurable lesion according to RECIST version 1.1. 8. Estimated life expectancy ≥ 6 months. 9. Adequate hematological function: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. 10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula. 11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN. 12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
Exclusion criteria
1. Age ≥ 65 years old. 2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx). 3. Positive EGFR test result in tumor tissue. 4. Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available. 5. ECOG performance status 0-2 OR KPS score ≥ 60. 6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy. 7. At least one measurable lesion according to RECIST version 1.1. 8. Estimated life expectancy ≥ 6 months. 9. Adequate hematological function: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. 10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula. 11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN. 12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal | Percentage of patients achieving complete response (CR) or partial response (PR), assessed according to RECIST version 1.1. Only evaluable patients for tumor response will be included in analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year progression-free survival rate | From start of study treatment up to 24 months | Progression-free survival (PFS) is defined as the time from initiation of study treatment to documented disease progression (locoregional recurrence or distant metastasis) or death from any cause, whichever occurs first. The 2-year PFS rate is estimated by the Kaplan-Meier method. Imaging assessments are performed at 4 weeks and 12 weeks after radiotherapy completion, then every 3-months until disease progression, subject intolerance, withdrawal, or completion of 2-year follow-up. |
| 2-year locoregional control rate | From start of study treatment through 2-year follow-up | Locoregional control (LRC) is defined as the time from the start of study treatment until clinical or imaging-confirmed locoregional tumor recurrence (primary site or regional lymph nodes). Distant metastasis alone is not regarded as a locoregional control event. The 2-year locoregional control rate will be estimated using the Kaplan-Meier method. Tumor imaging assessments are performed at 4 weeks and 12 weeks after radiotherapy completion, then every 3 months until disease progression, subject intolerance, withdrawal, or completion of 2-year follow-up. |
| Overall survival | From start of study treatment through 2-year follow-up | Overall survival (OS) is defined as the time from initiation of study treatment to death from any cause. Patients who are alive will be censored at the end of 2-year follow-up. Survival status will be collected during regular follow-up visits. |
Countries
China
Contacts
CONTACTKe Hu
Outcome results
None listed