Actively Recruiting
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2023-10-13
72
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily joined the study, signed the informed consent, and had good compliance
- Patients aged 18 to 75 years at the time of consent
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1
- Untreated head and neck squamous cell carcinoma confirmed by pathology
- Cancer classified as stage III or IVa per AJCC 8th Edition
- Cancer sites include oral, oropharyngeal, hypopharyngeal, and laryngeal
- Female patients of reproductive age must agree to use birth control during the study and for six months after, have a negative serum pregnancy test within 7 days before enrollment, and not be lactating
- Male patients must agree to use contraception during the study and for six months after completion
You will not qualify if you...
- Previous treatment with PD-1, PD-L1, or CTLA-4 antibody therapy
- Need for systemic corticosteroids greater than 10 mg prednisone daily or other immunosuppressive drugs within 14 days before or during treatment
- History of active immune or autoimmune disease or previous allogeneic organ or stem cell transplantation
- Active or uncontrolled severe infection within 4 weeks before enrollment
- Abnormal function of major organs
- Concomitant diseases that may seriously risk safety or interfere with study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
M
Min Ruan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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