This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
200mg, iv, on day 1, 15, 29, 43
250 mg po, qd, 28 days as a cycle, 2 cycles in total
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate (CR+PR)
Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time frame: 9 weeks
Number of Participants With at Least One Grade 3-4 Toxicity
Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: 9 weeks
Overall Survival
Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months
Time frame: 2 years
Progression-Free Survival
Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months
Time frame: 2 years
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