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Recruiting NCT06081673

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

Phase II Interventional Head and Neck Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Penpulimab injection, cisplatin, albumin-paclitaxel.
Who it may be relevant to
Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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).
  • Drug cisplatin
    Cisplatin :75mg/m2, D1, IV(21 days/cycle)
  • Drug albumin-paclitaxel
    albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)

Primary outcome measures

  • Major pathological response（MPR） [Time frame: One year]
Secondary outcome measures (8)
  • Disease-control Rate（DCR） [Time frame: Baseline up to 3 years.]
  • Adverse event rate [Time frame: Baseline up to 3 years.]
  • Disease-free survival at 2 years(DFS at 2 years) [Time frame: Baseline up to 2 years.]
  • Overall Response Rate (ORR) [Time frame: Baseline up to 3 years.]
  • Local recurrence-free survival at 2years(LRFS at 2 years) [Time frame: Baseline up to 2 years.]
  • distant metastasis-free survival at 2 years(DMFS at 2 years) [Time frame: Baseline up to 2 years.]
  • OS at 2 years [Time frame: Baseline up to 2 years.]
  • pathologic complete response(pCR) [Time frame: One year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06081673 · ALTER-HN001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗