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

Recruiting now · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06081673

Run by

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

People needed

72

Starts

2023-10-30

Expected to finish

2026-10-30

Last updated by the study team

2023-10-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients voluntarily joined the study, signed the informed consent, and had good compliance;
• Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1;
• Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers
• Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

You may not qualify if…

• Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy;
• Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted;
• A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection);
• Abnormal function of major organs
• Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.

Where it is running

• Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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