Actively Recruiting
A Pilot Study to Assess Feasibility and Preliminary Efficacy of Neoadjuvant Nimotuzumab, Toripalimab, and Chemotherapy in Locally Advanced Tonsillar Cancer
Led by Tang-Du Hospital · Updated on 2026-01-20
10
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining nimotuzumab, toripalimab, and chemotherapy to treat patients with locally advanced tonsillar cancer. This prospective, single-arm Phase II study aims to see if this combination can improve the pathological complete response rate and overall survival compared to historical data. Approximately 10 patients will be enrolled with a follow-up period extending up to five years after enrollment to monitor long-term outcomes. Participants receive nimotuzumab (400 mg), toripalimab (240 mg), nab-paclitaxel (260 mg/m²), and carboplatin through intravenous infusions every three weeks for 2 to 4 cycles. Each infusion lasts at least 60 minutes with careful monitoring for reactions. After 2 to 4 cycles of this neoadjuvant combination therapy, patients undergo endoscopy and imaging evaluation around day 42 to assess response. Throughout the study, participants will have assessments including pathological examination within 1 to 2 weeks after radical surgery to measure the pathological complete response rate, surgical margins, and major pathological response. Radiological response rates are evaluated after completing two treatment cycles, and functional status is assessed before surgery and at 1 month, 6 months, and 1 year post-surgery or concurrent chemoradiotherapy. Disease-free survival will be followed for up to 72 months. Participants must comply with study procedures and follow-up visits during this period.
CONDITIONS
Brief Title
Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years old, any gender
- Confirmed resectable locally advanced tonsillar squamous cell carcinoma by MRI
- At least one measurable lesion per RECIST 1.1 criteria
- Male participants must agree to contraceptive measures or abstinence during treatment and for 180 days after
- Female participants must not be pregnant or breastfeeding and agree to contraceptive measures or abstinence during treatment and for 210 days after
- ECOG Performance Status 0-2 within 3 days before treatment
- Evidence of extranodal extension in lymph nodes
- Voluntary written informed consent
- Expected survival time of at least 6 months
- Adequate organ function confirmed by lab tests
- Good compliance and willingness to follow study procedures
You will not qualify if you...
- Prior systemic therapy for advanced or unresectable tonsillar cancer, except allowed neoadjuvant/adjuvant therapy completed at least 6 months prior
- Active autoimmune disease requiring systemic therapy within past 2 years
- Major surgery with incomplete recovery before study
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or EGFR-targeted agents
- Anti-tumor therapy within 4 weeks before enrollment
- Unresolved adverse events from prior cancer therapy above Grade 1
- Radiotherapy within 2 weeks before investigational treatment start without recovery
- Live vaccination within 30 days before first dose
- Participation in other investigational drug or device studies within 4 weeks before first dose
- Immunodeficiency or recent systemic corticosteroid/immunosuppressive therapy
- Recent invasive malignancy requiring active treatment within 3 years
- Severe hypersensitivity to study drugs
- History or current pneumonitis requiring corticosteroids
- Active infection requiring systemic therapy
- Known HIV infection
- Active tuberculosis
- Severe uncontrolled diseases
- Major surgery within 30 days before first dose or planned surgery during study
- CNS metastases or carcinomatous meningitis
- Psychiatric illness or substance abuse interfering with participation
- Allogeneic tissue or organ transplantation
- Unwillingness or inability to consent to the study
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.
Screening and enrollment visit
Duration - 6 to 12 weeks
Participants receive neoadjuvant treatment with Nimotuzumab, Toripalimab, Nab-paclitaxel, and Carboplatin administered intravenously every 3 weeks for 2 to 4 cycles.
2 to 4 infusion visits every 3 weeks
Duration - Approximately 3 weeks
After completion of 2 cycles of neoadjuvant treatment, participants undergo endoscopy combined with imaging evaluation followed by radical surgery performed 2 to 3 weeks later.
1 surgery visit and 1 imaging/endoscopy visit
Duration - Up to 5 years
Participants are followed for functional preservation assessments and disease-free survival monitoring for up to 5 years after treatment initiation.
Visits at 1 month, 6 months, 1 year, and periodic visits up to 5 years
Trial Site Locations
Total: 1 location
1
Tangdu Hospital, Air Force Medical University, Xi'an 710038, Shaanxi Province, China
Shanxi, Province, China
Actively Recruiting
Research Team
Z
Zhao DaQing
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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