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NCT Number: NCT06081673

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Shanghai, Shanghai Municipality, 200011, China

Location status: Recruiting

Location contact

Min Ruan, PhD

CONTACT

[email protected]

18019790370

Min Ruan, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Cisplatin

Drug

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

albumin-paclitaxel

Drug

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

Primary outcomes

  1. Major pathological response(MPR)

    Time frame: One year

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

Secondary outcomes

  1. Disease-control Rate(DCR)

    Time frame: Baseline up to 3 years.

    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).

  2. Adverse event rate

    Time frame: Baseline up to 3 years.

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

  3. Disease-free survival at 2 years(DFS at 2 years)

    Time frame: Baseline up to 2 years.

    The proportion of subjects disease-free survival at 2 years

  4. Overall Response Rate (ORR)

    Time frame: Baseline up to 3 years.

    The proportion of subjects who achieves a best overall response of CR or PR.

  5. Local recurrence-free survival at 2years(LRFS at 2 years)

    Time frame: Baseline up to 2 years.

    The proportion of subjects local recurrence-free survival at 2years

  6. distant metastasis-free survival at 2 years(DMFS at 2 years)

    Time frame: Baseline up to 2 years.

    The proportion of subjects distant metastasis-free survival at 2years

  7. OS at 2 years

    Time frame: Baseline up to 2 years.

    The overall survival time refers to the time from initiating inductive therapy to death due to any cause.

  8. pathologic complete response(pCR)

    Time frame: One year

    Pathological examination showed the presence of 0% active tumor in the tissue specimen

Study contacts

Contact information is provided by the study sponsor or research team.

Min Ruan, PhD

CONTACT

[email protected]

18019790370

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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