The purpose of this study is to determine the efficacy and safety of pulsed radiotherapy given concomitantly with Tislelizumab and as maintenance therapy in participants with locoregionally recurrent head and neck squamous cell carcinoma ( HNSCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Administered as an intravenous (IV) infusion 200mg every 3 weeks (Q3W)
66-70Gy/33-35Fx, 2Gy/Fx.
Sichuan Cancer Hosiptal
Chengdu, Sichuan, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGObjective response rate (ORR) using iRECIST 1.1 criteria
ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with RT, referred to as "Target lesion (RT+ Tisle), as well as the lesion(s) not treated with RT (if applicable), referred to as "Target lesion (Tisle only)", per the prescribed treatment.
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
Adverse Events (AEs)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
Time frame: From time of first dose of study treatment until the end of follow-up (up to 2 years)
Duration of Response (DOR)
The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
Progression Free Survival (PFS)
PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
Change From Baseline Quality of Life (GHS/QoL)
Change from baseline in QoL using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H\&N35)
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Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)