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

NCT07535567 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026HN02
• Study Type: interventional
• Target: 386
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

intermediate-risk pathological risk factor

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS）

  From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause

  3-year

Secondary Outcomes (4)

• Overall Survival (OS)

  3-year

• Adverse Events (AEs)

  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

Study Arms (2)

IMRT-Nimotuzumab + Benmelstobart

EXPERIMENTAL

Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy

Drug: Nimotuzumab, Benmelstobart; Radiation: Postoperative Radiotherapy

IMRT-Nimotuzumab

ACTIVE COMPARATOR

Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT)

Drug: Nimotuzumab; Radiation: Postoperative Radiotherapy

Interventions

Nimotuzumab DRUG

Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.

IMRT-Nimotuzumab

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.

IMRT-Nimotuzumab + Benmelstobart

Postoperative Radiotherapy RADIATION

Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)

IMRT-Nimotuzumab; IMRT-Nimotuzumab + Benmelstobart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Guopei Zhu

CONTACT

86-23271699; antica@gmail.com

Wen Jiang

CONTACT

86-23271699; wjiang91@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share