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Clinical Trials in China / NCT06081673
Recruiting Phase 2

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

NCT06081673 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase
Phase 2
Started
2023-10-30
Last updated
2023-10-13

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Penpulimab injection →cisplatin →albumin-paclitaxel →

Penpulimab 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).

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

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

More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06081673 on ClinicalTrials.gov ↗ ← All trials in China