Induction Chemotherapy and Toripalimab for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma

Induction Chemotherapy and Toripalimab Followed by Surgery or Radiotherapy for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma

The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

Historically, induction chemotherapy could provide a chance of larynx preservation for approximate 60-70% of patients with locally advanced laryngeal/hypopharyngeal carcinoma. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

Inclusion Criteria:

• Pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma (T2-4a, N0-resectable N3, M0);
• Age between 18-75 years;
• Signed inform consent;
• Had at least one measurable lesion according to RECIST 1.1 criteria
• Anticipated overall survival more than 3 months;
• Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
• Normal organ function;
• HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
• Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

• Hypersensitivity to Toripalimab, Paclitaxel, Nab-Paclitaxel and Cisplatin;
• Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
• Severe, uncontrolled heart disease;
• Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
• Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
• Surgery or trauma within 28 days prior to signing the informed consent;
• Received other immune checkpoint inhibitors previously;
• Severe, uncontrolled infections within 28 days of prior to signing the informed consent;
• Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
• History of interstitial lung disease;
• HIV positive;
• Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
• Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
• Women of child-bearing potential who are pregnant or breastfeeding.