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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2,Cisplatin 25mg/m2 d2-4 q3w. Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If overall response rate of primary tumor is complete response or partial response, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 8 cycles (6 months). Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 8 cycles.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGLaryngeal Preservation rate at 3-month post-radiotherapy
defined as the absence of any residual disease that would justify salvage total laryngectomy
Time frame: 3-month post-radiotherapy
Overall response rate of induction therapy
Overall response rate of induction therapy evaluated by head and neck MR/CT, laryngoscopy using Recist 1.1 Criteria
Time frame: 2 weeks after the 3th cycle of induction therapy
Overall response rate of treatment
Overall response rate of treatment evaluated by head and neck MR/CT, laryngoscopy using Recist 1.1 Criteria
Time frame: 3 months post-radiotherapy
Pathological complete response rate of the patients receiving surgical resection
Pathological complete response rate of the patients receiving surgical resection, evaluated by experienced pathologists
Time frame: Within 3 weeks after surgery
Major pathologic response rate of the patients receiving surgical resection
Major pathologic response rate, defined as no more than 10% of residual viable tumor, evaluated by experienced pathologists.
Time frame: Within 3 weeks after surgery
Overall survival rate at 1 year
Overall survival rate at 1 year
Time frame: One year post-radiotherapy
Overall survival rate at 2 year
Overall survival rate at 2 year
Time frame: Two year post-radiotherapy
Yu Wang, M.D.
CONTACT
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Progression-free survival rate at 1 year
Progression-free survival rate at 1 year
Time frame: One year post-radiotherapy
Progression-free survival rate at 2 year
Progression-free survival rate at 2 year
Time frame: Two year post-radiotherapy
Laryngeal Preservation rate at 1 year
Laryngeal Preservation rate at 1 year
Time frame: One year post-radiotherapy
Laryngeal Preservation rate at 2 year
Laryngeal Preservation rate at 2 year
Time frame: Two year post-radiotherapy
Adverse Effect
Adverse Effect, evaluated by CTCAE 4.0.03
Time frame: One year post-radiotherapy