Safety and Efficacy of Pembrolizumab in Combination With Low-dose PF (Cisplatin and 5-Fluorouracil) as Neoadjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multi-center, Single-arm Clinical Study Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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)

• ECOG performance status of 0 or 1

• Selective standard surgery+ standard adjuvant chemo-radiotherapy/radiotherapy as judged by the investigator

• No active autoimmune disease

• No concurrent malignancy

• Life expectancy is estimated to be over 3 months

⁃ Have sufficient tumour tissue samples available for CPS PD-L1 immunohistochemical examination (22C3 DAKO)

⁃ No abvious signs of hematological disorders, ANC≥1.5×109 /L, platelets ≥100×109 /L, Hb≥ 90 g/L,WBC ≥3.0×109 /L before enrollment, no blood transfusion and bleeding tendency within 7 days

⁃ ALT,AST and ALP ≤ 2.5 × upper limit of normal (ULN); Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN

⁃ Serum creatinine ≤1.5 or creatinine clearance\>50 mL/min

⁃ HPV status determined by p16 IHC, in situ hybridization, or by polymerase chain reaction-based assays

⁃ Able to understand this study, patient and (or) legal representative voluntarily agree to participate in this trial and sign informed consent

Locations
Other Locations
China
Sir Run Run Shaw Hospital School of Medicine,Zhejiang University
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Tianjin Cancer Hospital Airport Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Jiajie Xu, PhD
03kqyxxjj@163.com
+86 13600517252
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 80
Treatments
Experimental: Pembrolizumab+cisplatin + 5-fluorouracil
Pembrolizumab+ cisplatin+ 5-fluorouracil+ surgery+ adjuvant treatment+ pembrolizumab maintenance
Sponsors
Leads: Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov