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

April 24, 2026 updated by: Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

386

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT-Nimotuzumab + Benmelstobart
Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy
Drug: Nimotuzumab, 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.

Radiation: Postoperative Radiotherapy
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)
Active Comparator: IMRT-Nimotuzumab
Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT)
Radiation: Postoperative Radiotherapy
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)
Drug: Nimotuzumab
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS）
Time Frame: 3-year
From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional Recurrence-Free Survival (LRRFS)
Time Frame: From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled
From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled
Distant Metastasis-Free Survival (DMFS)
Time Frame: From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled
From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled
Overall Survival (OS)
Time Frame: 3-year
From enrollment until death from any cause
3-year
Adverse Events (AEs)
Time Frame: 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).
30 days after the last dose (approximately 8 weeks total).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026HN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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