OncoMatch/Clinical Trials/NCT06039631
Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer
Is NCT06039631 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab for larynx cancer.
Treatment: Toripalimab — In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%. Past approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year. Against this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T2N+M0, T3-T4AN0-3M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immunotherapy — neoadjuvant
Patients who have received neoadjuvant immunotherapy combined with chemotherapy and have achieved a partial response (PR) in the primary lesion according to RECIST 1.1 criteria and are suitable candidates for organ preservation surgery.
Must have received: chemotherapy — neoadjuvant
Patients who have received neoadjuvant immunotherapy combined with chemotherapy and have achieved a partial response (PR) in the primary lesion according to RECIST 1.1 criteria and are suitable candidates for organ preservation surgery.
Cannot have received: investigational drug
Use of any investigational drug within 4 weeks prior to the first dose of study treatment.
Cannot have received: systemic corticosteroids or other immunosuppressive medications
Exception: excluding corticosteroids for localized inflammation or prophylaxis against allergies or nausea/vomiting; inhaled or topical steroids and adrenal replacement therapy with a dose of >10 mg/day prednisone or equivalent are allowed
Requiring systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of study treatment, excluding corticosteroids for localized inflammation or prophylaxis against allergies or nausea/vomiting. Other specific circumstances should be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a dose of >10 mg/day prednisone or equivalent are allowed.
Cannot have received: anti-tumor vaccine or live vaccine
Exception: COVID-19 vaccine allowed with 2-week interval
Vaccination with anti-tumor vaccines or administration of live vaccines within 4 weeks prior to the first dose of study treatment (for patients who received COVID-19 vaccine, a 2-week interval is required).
Cannot have received: major surgery
Major surgery within 4 weeks before the first dose of study treatment or presence of severe trauma.
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Hemoglobin ≥9 g/dL; Serum albumin ≥2.8 g/dL
Kidney function
Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤1.5× ULN, ALT, AST, and/or ALP ≤3× ULN
Good organ function, meeting the following criteria: Absolute neutrophil count (ANC) ≥1.5×10^9/L. Platelet count ≥100×10^9/L. Hemoglobin ≥9 g/dL. Serum albumin ≥2.8 g/dL. Total bilirubin ≤1.5× ULN, ALT, AST, and/or ALP ≤3× ULN. Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula). Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5× ULN (patients on stable doses of anticoagulation with agents like low molecular weight heparin or warfarin, and INR within the expected therapeutic range, may be included).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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