To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
HCC patients waiting for liver transplantation will be screened and enrolled according to the inclusion criteria. After screening and enrollment, patients will be administrated camrelizumab 200mg q2w iv and apatinib 250mg qd po regimen every 4 weeks as a cycle. Each patient will receive camrelizumab treatment for at least 2 cycles and discontinue camrelizumab 5 weeks before liver transplantation. Apatinib will be discontinued 1 week before liver transplantation. Once the tumor progression was detected, the program will be terminated and the appropriate optimal treatment will be given. The objective remission rate (ORR), recurrence-free survival (RFS), overall survival (OS), time to progress (TTP) and any adverse effect during the study will be evaluated in order to assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Camrelizumab 200mg q2w iv and apatinib 250mg qd po.
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGObjective remission rate
The proportion of patients with CR, PR, and SD in the group
Time frame: From enrollment to disease progression, up to 6 months
Recurrence-free survival
The period from enrollment surgery to recurrence of HCC
Time frame: 1 year
Overall survival
The survival rate in a year
Time frame: 1 year
Time to progress
The period from enrollment to disease progression
Time frame: From enrollment to disease progression, up to 6 months
Adverse effect
Any adverse effects occur during the project
Time frame: 1 year
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