Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days. The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Patients will be treated with camrelizumab alone.
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Binzhou Medical University Hospital
Binzhou, Shandong, China
RECRUITINGDezhou People's Hospital
Dezhou, Shandong, China
Objective response rate
ORR
Time frame: The proportion of Patients achieved complete response or partial response up to 16 weeks
Overall survival
OS
Time frame: From date of randomization until the date of first documented date of death from any cause,assessed up to 24 months
Progression free survival
OS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety
The adverse events of both microwave and camrelizumab
Time frame: The proportion and grade of patients had adverse events up to 24 months
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The Second People's Hospital of Dezhou
Dezhou, Shandong, China
RECRUITINGJinan Military General Hospital
Jinan, Shandong, China
RECRUITINGAffliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, China
RECRUITINGShandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, China
RECRUITINGAffliated Hospital of Jining Medical University
Jining, Shandong, China
RECRUITINGLiaocheng Cancer Hospital
Liaocheng, Shandong, China
RECRUITINGAffliated Hospital of Taishan Medical University
Taian, Shandong, China
RECRUITINGThe People's Liberation Army 88 Hospital
Taian, Shandong, China
RECRUITING...and 3 more locations