Actively Recruiting
Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-04-17
370
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ineligible for cisplatin chemotherapy due to any of the following: older than 70 years, renal insufficiency (creatinine clearance < 50 mL/min), severe hearing impairment, inability to receive intravenous hydration, neuropathy greater than Grade 1, or patient refusal
- Histologically confirmed locally advanced head and neck squamous cell carcinoma (Stage III-IVB, AJCC 8th edition), including oral cavity cancer, HPV-negative or unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer
- Underwent radical surgery with at least one high-risk feature: extracapsular extension of lymph node metastasis, close (< 1 mm) or positive surgical margin, four or more metastatic lymph nodes, or multiple perineural invasions
- No evidence of distant metastasis on imaging
- Sufficient tumor tissue available for biomarker testing (EGFR, PD-L1, HPV/p16)
- Expected survival of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate blood counts: WBC ≥ 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L
- Adequate kidney function: serum creatinine ≤ 1.5 × upper limit of normal or creatinine clearance > 50 mL/min
- Adequate liver function: total bilirubin ≤ 1.5 × upper limit of normal; AST and ALT ≤ 2.5 × upper limit of normal
- Women of childbearing potential must have a negative pregnancy test within 14 days before enrollment and agree to use effective contraception during the study
- Male participants must use effective contraception from the start of treatment until 180 days after the last study drug administration
- Voluntary participation, signed informed consent, good compliance, and willingness to follow study procedures
You will not qualify if you...
- Prior radiotherapy for head and neck cancer before enrollment
- Previous treatment with similar immunological or targeted agents
- Participation in another interventional clinical trial within 30 days before screening
- Presence of distant metastasis
- History of other cancers within the past 5 years except certain cured or localized cancers
- Uncontrolled medical conditions such as heart failure, diabetes, hypertension, thyroid disease, or psychiatric disorders
- Known HIV infection, active viral hepatitis, or active tuberculosis
- Major surgery within 30 days before starting study treatment or planned major surgery during the study
- Allergy or hypersensitivity to any study drugs or their components
- Pregnancy or breastfeeding; unwillingness or inability to use effective contraception during and for 6 months after the study
- Considered unsuitable for the study by the investigator
- Unwilling or unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai 9th people's hospital
Shanghai, China, 200011
Actively Recruiting
Research Team
G
Guopei Zhu
CONTACT
S
Shengjin Dou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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