This is an open-label, single-center, single-arm phase Ib clinical trial. The aim of this study is to assess the safety and efficacy of JS014 in combination with Toripalimab and transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC). The primary endpoint is the safety and tolerability, while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), time to progression (TPP), progression-free survival (PFS), and overall survival (OS).
There is already existing evidence indicating that the efficacy of PD-1/PD-L1 therapy is closely associated with the immune response status within the tumor microenvironment. Researchers are now embarking on exploring immune-activating treatment approaches that can synergize with immunotherapy in the battle against cancer. This includes local treatments such as radiation therapy and local ablation therapy, which can induce local inflammation and release antigens to activate anti-tumor immune responses and enhance the efficacy of PD-1 antibodies. Multiple preclinical studies have confirmed that transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) can induce immunogenic necrosis and activate anti-tumor immune responses. This study is designed to investigate the safety and efficacy of TACE combined with JS014 and Toripalimab in the treatment of advanced liver cancer. It is an open-label, single-center, single-arm phase Ib clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
JS014 (60μg/kg,QW)+Toripalimab (240mg , Q3W)+ dTACE (60mg/m2)
Xiangya Hospital
Changsha, Hunan, China
The rate of adverse events
Safety and tolerability
Time frame: Two years
ORR (RECIST 1.1)
Objective response rate
Time frame: Two years
DCR
disease control rate
Time frame: Two years
PFS
Progression free survival
Time frame: Two years
TTP
time to progress
Time frame: Two years
OS
Overall survival
Time frame: Two years
ORR(mRECIST)
Objective response rate
Time frame: Two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.