Actively Recruiting
Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-04-17
370
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of postoperative radiotherapy combined with Nimotuzumab followed by Bemcentinib in patients with high-risk head and neck squamous cell carcinoma who cannot receive cisplatin chemotherapy. This Phase III multicenter clinical trial aims to improve disease-free survival in this specific group of patients. A total of 370 patients will be enrolled and monitored over a planned period of 3 years after the last patient joins the study. Participants will be randomly assigned to either the study group or the control group. The study group will receive intensity-modulated radiation therapy (IMRT) at doses of 60-66 Gy over 30-33 sessions, along with weekly Nimotuzumab injections for 7 weeks. After radiotherapy, Bemcentinib will be given orally at 1200 mg every 3 weeks for up to 17 cycles. The control group will receive standard postoperative care without this combination treatment. During the trial, patients will undergo regular assessments including imaging to check for cancer recurrence or spread, blood tests, and quality of life questionnaires. Researchers will monitor disease-free survival as the main outcome, along with overall survival, recurrence rates, distant metastasis, and treatment side effects. The study includes safety monitoring for adverse events during treatment and follow-up for up to 3 years. Participants are expected to complete the study with ongoing evaluations of health and quality of life.
CONDITIONS
Brief 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 age over 70, renal insufficiency, severe hearing loss, 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) including oral cavity, HPV-negative/unrelated oropharyngeal, hypopharyngeal, and laryngeal cancers
- Underwent radical surgery with at least one high-risk feature such as extracapsular extension, close or positive surgical margins, 4 or more metastatic lymph nodes, or multiple perineural invasions
- No distant metastasis on imaging
- Sufficient tumor tissue for EGFR, PD-L1, and HPV/p16 testing
- Expected survival of 6 months or more
- ECOG performance status of 0-1
- Adequate blood, kidney, and liver function
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception; males must agree to contraception during and after treatment
- Voluntary participation with signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Prior radiotherapy for head and neck cancer
- 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 malignancies within 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 tuberculosis
- Major surgery within 30 days before starting study medication or planned surgery during the study
- Allergy or hypersensitivity to study drugs or their components
- Pregnancy or lactation; unwillingness or inability to use effective contraception
- Considered inappropriate for participation by the investigator
- Unwillingness or inability to provide informed consent or participate in the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 58 weeks (7 weeks of radiotherapy and Nimotuzumab, then up to 51 weeks of Bemcentinib)
Participants receive postoperative radiotherapy combined with weekly Nimotuzumab for 7 weeks, followed by Bemcentinib every 3 weeks for up to 17 cycles.
Weekly visits for 7 weeks during radiotherapy and Nimotuzumab treatment, then visits every 3 weeks for Bemcentinib administration
Trial Site Locations
Total: 1 location
1
Shanghai 9th people's hospital
Shanghai, China, 200011
Actively Recruiting
Research Team
G
Guopei Zhu
S
Shengjin Dou
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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