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

NCT06081673 | Recruiting Phase 2

• 1 other identifier: ALTER-HN001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathological response（MPR）

  Major pathologic response is based on the pathological examination on the post-operative specimens.

  One year

Secondary Outcomes (8)

• Disease-control Rate（DCR）

  Baseline up to 3 years.

• Adverse event rate

  Baseline up to 3 years.

• Disease-free survival at 2 years(DFS at 2 years)

  Baseline up to 2 years.

• Overall Response Rate (ORR)

  Baseline up to 3 years.

• Local recurrence-free survival at 2years(LRFS at 2 years)

  Baseline up to 2 years.

Study Arms (1)

Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy

EXPERIMENTAL

Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle. Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab). Non-MPR patients receive standard adjuvant therapy

Drug: Penpulimab injection; Drug: cisplatin; Drug: albumin-paclitaxel

Interventions

Penpulimab injection DRUG

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).

Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy

cisplatin DRUG

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

Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy

albumin-paclitaxel DRUG

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

Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

penpulimab; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Min Ruan, PhD

CONTACT

18019790370; doctorruanmin@situ.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 13, 2023
• Study Start: October 30, 2023
• Primary Completion: December 30, 2024
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 13, 2023

Record last verified: 2023-05

Locations

CN (1)