The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.
Historically, induction chemotherapy has been shown to increase laryngeal-preservation rate, improve disease-free survival and reduce the risk of distant metastasis. However, the prognosis of locally advanced laryngeal/ hypopharyngeal carcinoma remains poor. 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) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2,Cisplatin 25mg/m2 d2-4 q3w. Then a total dose of 70Gy in 35 fractions was administered, with concurrently weekly cisplatin (30mg/m2 qw). At 3-6 weeks post-radiotherapy, maintenance Toripalimab was administered for 8 cycles (240mg d1 q3w, in total 8 cycles).
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival
From the rate of enrollment to first progression
Time frame: 2 year
Overall response rate of induction chemotherapy
Overall response rate of induction chemotherapy, evaluated by MR/CT imaging per RECIST 1.1
Time frame: up to 3 month
Locoregional recurrence-free survival
From the rate of enrollment to first locoregional relapse
Time frame: 2 year
Distant metastasis-free survival
From the rate of enrollment to first distant metastasis
Time frame: 2 year
Overall survival
From the rate of enrollment to death
Time frame: 2 year
Laryngeal Preservation Rate
The incidence of those with partial/whole preservation of anatomic larynx, without evidence of local recurrence
Time frame: 2 year
Adverse Effect
Adverse Effect, evaluated by CTCAE 4.0.03
Time frame: up to 2 year
Yu Wang, M.D.
CONTACT
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