This is a prospective clinical study to investigate the safety and efficacy of anti-PD-1 immunotherapy (Camrelizumab) in patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation. All of the enrolled patients have a background of liver transplantation for HCC. Due to the tumor recurrence, patients are not suitable for curative surgical resection, and targeted therapy provides poor therapeutic effect, leading to tumor progression or intolerance. Before immunotherapy, the PD-L1 expression was confirmed negative in the graft liver by immunohistochemistry, and patients continued targeted therapy as part of a combined antitumor regimen. In addition, the immunosuppression schedule is also reduced to a low level.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Camrelizumab (SHR-1210), 200mg, I.V., Q3W
Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate (ORR)
Objective Response Rate after Camrelizumab treatment according to the mRECIST
Time frame: 2 years
Overall Survival (OS)
Time from the initiation of Camrelizumab treatment to the patient death from any cause
Time frame: 2 years
Progression-free Survival (PFS)
Time from the initiation of Camrelizumab treatment to radiological tumor progression or death from any cause
Time frame: 2 years
Time to Progression (TTP)
Time from the initiation of Camrelizumab treatment to radiological tumor progression
Time frame: 2 years
Serious Adverse Event (SAE)
The incidence of serious adverse event caused by Camrelizumab treatment
Time frame: 2 years
Graft Rejection (GR)
The incidence of graft rejection during the Camrelizumab treatment
Time frame: 2 years
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