Actively Recruiting
Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Led by Zhejiang Provincial People's Hospital · Updated on 2025-08-20
80
Participants Needed
7
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF (cisplatin + 5-fluorouracil) in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma
CONDITIONS
Official Title
Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years old
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, stage III or IV A without distant metastasis
- Measurable primary lesions according to RECIST 1.1 criteria
- No previous disease-related treatment except diagnostic biopsies
- ECOG performance status of 0 or 1
- Planned standard surgery plus standard adjuvant chemo-radiotherapy or radiotherapy
- No active autoimmune disease
- No concurrent malignancies
- Estimated life expectancy over 3 months
- Available tumor tissue for PD-L1 immunohistochemical examination
- Adequate blood counts without recent transfusion or bleeding
- Liver enzymes and bilirubin within specified limits
- Serum creatinine ≤1.5 or creatinine clearance >50 mL/min
- HPV status determined by appropriate testing
- Ability to understand the study and provide informed consent
You will not qualify if you...
- Multiple organ failure
- HPV p16 positive oropharyngeal cancer
- Locally advanced head and neck squamous cell carcinoma stage T4B and/or N3
- Distant metastasis
- Uncontrolled serious diseases (heart, cerebrovascular, diabetes, hypertension, infection, peptic ulcer)
- Dementia, altered mental status, or mental illness preventing consent or questionnaire completion
- Grade 2 or higher peripheral neuropathy or hearing impairment
- Allergy or hypersensitivity to study drugs
- Malignancy within 5 years prior to screening except certain treated cancers without recurrence
- Known HIV or AIDS
- Nasopharyngeal carcinoma or squamous cell carcinoma outside oral cavity, oropharynx, larynx, hypopharynx
- Participation in other clinical trials or investigational therapies within 30 days
- Recent systemic corticosteroids or immunosuppressive drugs within 14 days
- Pregnancy or breastfeeding; refusal of contraception if of childbearing age
- Unfit for study as assessed by investigator
- Recent systemic antibiotics or active infection
- Known hepatitis B or active hepatitis C infection
- Receipt of live vaccine during study or within 30 days prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266555
Not Yet Recruiting
2
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
3
Sir Run Run Shaw Hospital School of Medicine,Zhejiang University
Hangzhou, China
Actively Recruiting
4
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
5
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Actively Recruiting
6
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
Actively Recruiting
7
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
Research Team
J
Jiajie Xu, PhD
CONTACT
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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