Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Head and Neck Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Head and neck squamous cell carcinoma (HNSCC) refers to a series of tumors that occur in the head and neck region, including the oral cavity, pharynx, larynx, nasal cavity, paranasal sinuses, thyroid ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06894459
Start Date
May 8 2025
End Date
December 1 2028
Last Update
April 30 2025
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