The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.
75-100 mg/m\^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.
66-70 Gy given in 33-35 fractions over 6-7 weeks.
Objective Response Rate
The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
Time frame: 6 months
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Time frame: Up to 5 years
Disease-free Survival (DFS)
DFS is the time from the date of randomization to the date of first record of disease recurrence or death.
Time frame: Up to 5 years
Acute Adverse Events (AEs)
The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
Time frame: Up to 6 months
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