Status:
RECRUITING
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 car...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06081673
Start Date
October 30 2023
End Date
October 30 2026
Last Update
October 13 2023
Active Locations (1)
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1
Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011