Actively Recruiting
A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-05-22
182
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of nimotuzumab with PD-1 inhibitors and chemotherapy as a neoadjuvant treatment for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This phase II randomized controlled study aims to assess the efficacy and safety of this treatment approach, with the main goal being to measure the 2-year event-free survival rate. Enrollment is planned to finish within two years, and all patients will be followed for at least two years after the last patient joins the study. Participants in the study will be randomly assigned to one of two groups. The experimental group will receive nimotuzumab, albumin-bound paclitaxel, and cisplatin on days 3 and 24, along with either tislelizumab or pembrolizumab on days 1 and 22, over two cycles. After this neoadjuvant treatment, patients will undergo standard radical surgery. The control group will receive standard care surgery alone. Following surgery, patients may receive concurrent chemoradiotherapy including intensity modulated conformal radiotherapy and weekly chemotherapy or targeting treatments as specified. During the study, participants will undergo various assessments including tumor tissue testing for PD-L1, p16 immunohistochemistry for oropharyngeal carcinoma, and imaging to measure lesions. Researchers will monitor event-free survival over two years, as well as secondary outcomes such as major pathologic response, pathological complete response, objective response rate after two treatment cycles, overall survival, and quality of life at multiple time points. Safety and adherence will also be observed throughout the study period, which lasts at least two years following the last patient's enrollment.
CONDITIONS
Brief Title
Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition
- Resectable disease assessed by a multidisciplinary team including surgical, radiological, and pathological specialists
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- For oropharyngeal carcinoma: mandatory p16 immunohistochemistry
- Availability of tumor tissue for PD-L1 testing
- At least one measurable lesion per RECIST 1.1
- Life expectancy of 6 months or more
- Adequate hematologic function (white blood cell count ≥4.0×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L)
- Adequate renal function (serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60 mL/min)
- Adequate hepatic function (total bilirubin ≤1.5× upper limit of normal, AST and ALT ≤2.5× upper limit of normal)
- Female subjects must have a negative pregnancy test within 2 weeks before first study drug and be non-lactating
- Both females and males must agree to use highly effective contraception during the study and for 6 months after last study drug
- Written informed consent and willingness to comply with study visits and protocol requirements
You will not qualify if you...
- Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment
- Participation in another interventional clinical trial within 30 days prior to screening
- Unable to tolerate or contraindicated for platinum-based chemotherapy
- Unresectable disease, poor condition for surgery, refusal of surgery, or excessive tumor burden preventing resection
- History of other malignancy within 5 years except cured basal cell carcinoma of the skin
- History of primary immunodeficiency disease
- Uncontrolled comorbidities including heart failure, severe pulmonary or hepatic disease, psychiatric disorders
- Known HIV infection, active viral hepatitis, or active tuberculosis
- Major surgery within 90 days prior to first study drug or planned major surgery unrelated to this cancer
- Hypersensitivity to study drugs or components
- Pregnant or lactating women or unwilling/unable to use effective contraception
- Investigator considers subject unsuitable for study
- Unwilling or unable to provide informed consent
- Receipt of live vaccine within 30 days before first study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 weeks (2 cycles of 3 weeks each)
Participants receive nimotuzumab, PD-1 inhibitors (tislelizumab or pembrolizumab), albumin-bound paclitaxel or docetaxel, and cisplatin or carboplatin in two cycles before surgery.
2 treatment cycles with infusions on days 1 and 3 of each cycle
Duration - Single surgical procedure
Participants undergo standard radical surgery of the tumor.
1 surgery visit
Duration - 6 to 7 weeks
Participants receive intensity modulated conformal radiotherapy combined with weekly cisplatin chemotherapy and weekly nimotuzumab targeting therapy after surgery.
Weekly visits for chemoradiotherapy sessions totaling 6 to 7 visits
Duration - Up to 2 years
Participants are monitored for quality of life and survival up to 2 years after last treatment.
Follow-up visits at 6 months, 12 months, and 24 months after treatment completion
Trial Site Locations
Total: 1 location
1
Shanghai First People's Hospital
Shanghai, China
Actively Recruiting
Research Team
X
xin wei chen
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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