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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT-Nimotuzumab + Benmelstobart | Experimental | Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy |
|
| IMRT-Nimotuzumab | Active Comparator | Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) | From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From enrollment until death from any cause | 3-year |
| Adverse Events (AEs) | From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total). |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guopei Zhu | Contact | 86-23271699 | 5665 | antica@gmail.com |
| Wen Jiang | Contact | 86-23271699 | 5665 | wjiang91@163.com |
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| Nimotuzumab, Benmelstobart | Drug | 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. |
|
| Postoperative Radiotherapy | Radiation | Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions) |
|
| 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 |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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