This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Penpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2); 200mg,D1, IV(21 days/cycle).
Cisplatin :75mg/m2, D1, IV(21 days/cycle)
albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)
Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMajor pathological response(MPR)
Major pathologic response is based on the pathological examination on the post-operative specimens.
Time frame: One year
Disease-control Rate(DCR)
The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks).
Time frame: Baseline up to 3 years.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 3 years.
Disease-free survival at 2 years(DFS at 2 years)
The proportion of subjects disease-free survival at 2 years
Time frame: Baseline up to 2 years.
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Time frame: Baseline up to 3 years.
Local recurrence-free survival at 2years(LRFS at 2 years)
The proportion of subjects local recurrence-free survival at 2years
Time frame: Baseline up to 2 years.
distant metastasis-free survival at 2 years(DMFS at 2 years)
The proportion of subjects distant metastasis-free survival at 2years
Time frame: Baseline up to 2 years.
OS at 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
Time frame: Baseline up to 2 years.
pathologic complete response(pCR)
Pathological examination showed the presence of 0% active tumor in the tissue specimen
Time frame: One year