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Trial Title:
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
NCT ID:
NCT06081673
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Penpulimab injection
Description:
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).
Arm group label:
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
Intervention type:
Drug
Intervention name:
cisplatin
Description:
Cisplatin :75mg/m2, D1, IV(21 days/cycle)
Arm group label:
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
Intervention type:
Drug
Intervention name:
albumin-paclitaxel
Description:
albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)
Arm group label:
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200011
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Ruan, PhD
Phone:
18019790370
Email:
doctorruanmin@situ.edu.cn
Investigator:
Last name:
Min Ruan, PhD
Email:
Principal Investigator
Start date:
October 30, 2023
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Agency class:
Other
Source:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081673
