A Prospective, Multicenter, Multicohort Phase II Study: Evaluating the Efficacy and Safety of Preoperative Neoadjuvant Treatment With a PD-1 Inhibitor in Combination With Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Squamous Cell Carcinoma

Launched by BEIJING TONGREN HOSPITAL · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with locally advanced laryngeal and hypopharyngeal squamous cell carcinoma, which are types of cancers that affect the throat and voice box. The study aims to find out if combining a PD-1 inhibitor—a type of medication that helps the immune system fight cancer—with chemotherapy is more effective and safer than traditional chemotherapy alone. Patients eligible to participate must be at least 18 years old, have a confirmed diagnosis of laryngeal or hypopharyngeal cancer that has not been treated before, and be in good overall health. They should also be able to tolerate a specific chemotherapy medication called cisplatin.

Participants in this trial can expect to receive this combination treatment before any surgery, with the hope of reducing their tumors while preserving important functions like speaking and swallowing. The trial is not yet recruiting, but it represents a promising step towards better treatment options for patients facing advanced head and neck cancers. If you or someone you know is interested in participating, it’s essential to discuss eligibility and potential benefits with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with locally advanced laryngeal and hypopharyngeal squamous cell carcinoma who have been definitively diagnosed by histology and/or cytology, and whose TN staging meets: T1-4a, N0-3.
• • No prior treatment received.
• • Cisplatin-tolerant.
• • Age ≥18 years.
• • ECOG performance status of 0-1.
• • Measurable disease as defined by RECIST v1.1.
• • Normal organ function.
• • Women and men of reproductive potential must agree to use appropriate contraceptive methods throughout the study period and for 180 days after the last study treatment.
• • Male participants must not donate sperm during the entire study period and for 180 days after the last study treatment.
• Exclusion Criteria:
• • T stage is T4b.
• • Presence of distant metastasis.
• • Received live vaccines within 30 days prior to enrollment.
• • Diagnosed with an immunodeficiency or received systemic corticosteroid treatment or any other form of immunosuppressive therapy within 7 days prior to enrollment.
• • Have radiologically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis.
• • Have not fully recovered from surgery or from toxicities or complications due to interventions before starting the study.
• • Have a history of allogeneic tissue/solid organ transplantation.
• • Have had a severe hypersensitivity reaction (≥Grade 3) to PD-1 inhibitors, chemotherapy, or any of their excipients, or radiotherapy.
• • Have an active autoimmune disease that has required systemic therapy within the past 2 years.
• • Have a history of (non-infectious) pneumonitis that required treatment with corticosteroids.
• • Have a history of infection with the Human Immunodeficiency Virus (HIV).
• • Have a medical history that could confound study results or interfere with the participant during the study period.
• • Have a known history of psychiatric disorders or substance abuse.