Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
intermediate-risk pathological risk factor
Brief summary
A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.
Interventions
DRUGNimotuzumab
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.
DRUGNimotuzumab, Benmelstobart
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.
RADIATIONPostoperative Radiotherapy
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * ECOG performance status: 0-2 * Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining) * Completionof curative-intent surgery, with any of the following intermediate-risk factors present postoperatively: ①pT3-4a; ②N2 disease (excluding cases with extranodal extension); ③Closemargin \< 5 mm; ④Lymphovascular and/or perineural invasion; ⑤Invasion depth \> 5mm for T2 oral cavity cancer * Laboratory tests must meet the following criteria: ①Hematologic parameters (within 14 days without transfusion or blood products): a. Hemoglobin (Hb) ≥80 g/L; b.Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; c. Platelet count (PLT) ≥ 80 × 10⁹/L; ②Biochemical parameters: a. Bilirubin (BIL) \< 1.5 × upperlimit of normal (ULN); b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; * Expected survival time ≥ 6 months; * Women of child bearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use reliable contraception during the study period; Male subjects must use reliable contraception from before treatment initiation until 120 days after the last dose of study drug * With PD-L1 immunohistochemistry testing * Participant voluntarily agrees to participate in this study and signs the informed consent form
Exclusion criteria
* Pregnancy or lactation, or intention to become pregnant during the study period. * Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism. * Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation. * Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period. * Diagnosis of another malignancy within 3 years prior to enrollment. * History of Grade I or higher myocardial ischemia or myocardial infarction, severe arrhythmia, or ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification) within 6 months prior to enrollment. * Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment. * Prior treatment of immunotherapy (including PD-1/PD-L1/CTLA-4 antibodies) or anti-EGFR agents. * Known or suspected allergy to the investigational product or any drug related to this trial. * Any other severe medical condition that, in the investigator's judgment, may compromise patient safety or interfere with the subject's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS） | 3-year | From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3-year | From enrollment until death from any cause |
| Adverse Events (AEs) | 30 days after the last dose (approximately 8 weeks total). | From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total). |
| Locoregional Recurrence-Free Survival (LRRFS) | From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled | — |
| Distant Metastasis-Free Survival (DMFS) | From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled | — |
Contacts
CONTACTGuopei Zhu
CONTACTWen Jiang
Outcome results
None listed