RecruitingPhase 2NCT06081673

Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC

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


Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Enrollment

72 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug (penpulimab) to standard chemotherapy before and after surgery can improve outcomes in patients with resectable (operable) head and neck squamous cell cancer, including cancers of the mouth, throat, voice box, and windpipe area. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with head and neck squamous cell cancer (stage III or IVa) that has not been treated yet - Your tumor is considered operable by your surgical team - You have good overall performance status (ECOG 0-1) - Women of childbearing age must use contraception and have a negative pregnancy test **You may NOT be eligible if...** - You have previously received PD-1/PD-L1 immunotherapy (immune checkpoint therapy) - You need long-term systemic steroids or immunosuppressive drugs - You have an active autoimmune disease or history of organ/stem cell transplant - You have a serious uncontrolled infection - You have significant organ dysfunction or other conditions that put you at serious risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPenpulimab injection

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).

DRUGcisplatin

Cisplatin :75mg/m2, D1, IV(21 days/cycle)

DRUGalbumin-paclitaxel

albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)


Locations(1)

Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06081673


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