Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
Location status: Recruiting
NCT Number: NCT06081673
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200011, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: One year
Major pathologic response is based on the pathological examination on the post-operative specimens.
Time frame: Baseline up to 3 years.
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.
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 2 years.
The proportion of subjects disease-free survival at 2 years
Time frame: Baseline up to 3 years.
The proportion of subjects who achieves a best overall response of CR or PR.
Time frame: Baseline up to 2 years.
The proportion of subjects local recurrence-free survival at 2years
Time frame: Baseline up to 2 years.
The proportion of subjects distant metastasis-free survival at 2years
Time frame: Baseline up to 2 years.
The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
Time frame: One year
Pathological examination showed the presence of 0% active tumor in the tissue specimen
Contact information is provided by the study sponsor or research team.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Other
A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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