Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma

Starting soon · Phase 2/Phase 3

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT07535567
Run by: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
People needed: 386
Starts: 2026-05-05
Expected to finish: 2028-12-31
Last updated by the study team: 2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Full record on ClinicalTrials.gov

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