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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081673
• Other study ID #: ALTER-HN001
• Status: Recruiting
• Phase: Phase 2
• Start date: October 30, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: May 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Min Ruan, PhD
• Phone: 18019790370
• Email: doctorruanmin[@]situ.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 30, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response(MPR)	Major pathologic response is based on the pathological examination on the post-operative specimens.	One year
Secondary	Disease-control Rate(DCR)	The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for =4 weeks).	Baseline up to 3 years.
Secondary	Adverse event rate	The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).	Baseline up to 3 years.
Secondary	Disease-free survival at 2 years(DFS at 2 years)	The proportion of subjects disease-free survival at 2 years	Baseline up to 2 years.
Secondary	Overall Response Rate (ORR)	The proportion of subjects who achieves a best overall response of CR or PR.	Baseline up to 3 years.
Secondary	Local recurrence-free survival at 2years(LRFS at 2 years)	The proportion of subjects local recurrence-free survival at 2years	Baseline up to 2 years.
Secondary	distant metastasis-free survival at 2 years(DMFS at 2 years)	The proportion of subjects distant metastasis-free survival at 2years	Baseline up to 2 years.
Secondary	OS at 2 years	The overall survival time refers to the time from initiating inductive therapy to death due to any cause.	Baseline up to 2 years.
Secondary	pathologic complete response(pCR)	Pathological examination showed the presence of 0% active tumor in the tissue specimen	One year