Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorZhejiang Provincial People's Hospital
About this trial
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
Eligibility criteria
Qualifiers
Age ≥ 18 years old, ≤ 85 years old
Histologically or cytologically proven squamous cell carcinoma of the head and neck; Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon), including squamous cell carcinoma of oropharyngeal (P16-), oral cavity, hypopharyngeal and larynx
Measurable primary lesions per RECIST 1.1 criteria
Treatment-naive patients without any previous disease-related therapy (except for diagnostic biopsies on primary lesions)
Disqualifiers
Multiple organs failure
HPV p16 positive oropharyngeal cancer
Patients with local advanced head and neck squamous cell carcinoma stage T4B and/or N3
Patients with distant metastasis
Trial design
Treatments tested in this trial
- pembrolizumab+cisplatin + 5-FU
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov