Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

NCT07445048 | Recruiting Phase 3 DMC

• 1 other identifier: BPL-Nim-SCCHN-91
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.

Conditions

Head & Neck Squamous Cell Carcinoma; Head & Neck Cancer; Postoperative Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS

  From enrollment until disease recurrence, metastasis, second primary cancer, or death from any cause, assessed up to 3 years after last patient enrolled

Secondary Outcomes (6)

• Overall Survival (OS)

  From enrollment until death from any cause, assessed up to 3 years after last patient enrolled

• 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

• Change From Baseline in Global Quality of Life Score (EORTC QLQ-C30)

  Up to 24 months.

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).]

Study Arms (2)

Study Group

EXPERIMENTAL

Drug: Bemcentinib; Drug: Nimotuzumab; Radiation: radiotherapy

Control Group

ACTIVE COMPARATOR

Drug: Nimotuzumab; Radiation: radiotherapy

Interventions

Bemcentinib DRUG

1200 mg on Day 1, every 3 weeks (Q3W) for a total of 17 cycles, initiated 3-4 weeks after completion of radiotherapy.

Study Group

Nimotuzumab DRUG

200 mg on Day 1, once weekly (QW) for a total of 7 cycles.

Also known as: Nimotuzumab injection

Control Group; Study Group

radiotherapy RADIATION

Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60-66 Gy (2 Gy per fraction, 30-33 fractions). A boost to a clearly defined high-risk area may be applied at the investigator's discretion.

Control Group; Study Group

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.
• Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age \> 70 years;② Renal insufficiency (creatinine clearance \< 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy \> Grade 1;⑥ Patient refusal of chemotherapy.
• Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative/unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.
• Underwent radical surgery with at least one high-risk feature:
• Extracapsular extension (ECE) of lymph node metastasis; Close margin (\< 1 mm) or positive margin;
• metastatic lymph nodes, or multiple perineural invasions.
• No evidence of distant metastasis on imaging.
• Sufficient tumor tissue available for EGFR and PD-L1 testing; for oropharyngeal cancer, HPV/p16 testing is required (testing may be waived if results are already available).
• Expected survival ≥ 6 months.
• ECOG performance status 0-1.
• Adequate hematologic function:
• WBC ≥ 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
• Adequate renal function:Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) \> 50 mL/min (calculated by Cockcroft-Gault formula):
• Female: CrCl = (140 - Age) × Weight (kg) × 0.85 / (72 × Scr (mg/dL)) Male: CrCl = (140 - Age) × Weight (kg) × 1.00 / (72 × Scr (mg/dL))
• Adequate hepatic function:

You may not qualify if:

• Prior radiotherapy for head and neck cancer before enrollment.
• Prior treatment with similar immunological or targeted agents.
• Participation in another interventional clinical trial within 30 days prior to screening.
• Evidence of distant metastasis.
• History of other malignancy within the previous 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized differentiated thyroid cancer (papillary / follicular), localized prostate cancer, and ductal carcinoma in situ.
• Uncontrolled concurrent medical conditions (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.).
• Known HIV infection, active viral hepatitis, or active tuberculosis.
• Major surgical procedure within 30 days before the first dose of study medication, or planned major surgery during the study.
• Hypersensitivity to any study drug or their components.
• Pregnancy (confirmed by serum or urine HCG test) or lactating women; subjects of childbearing potential unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last study treatment.
• Subjects considered inappropriate for study participation by the investigator.
• Subjects unwilling to participate in the study or unable to provide written informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai 9th people's hospital

Shanghai, 200011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

bemcentinib; nimotuzumab; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Guopei Zhu

CONTACT

23211699-5665; antica@gmail.com

Shengjin Dou

CONTACT

17521066068; doushengjin@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 3, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): March 5, 2028
• Study Completion (Estimated): March 5, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)