The purpose of this study was to evaluate the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for the treatment of advanced liver cancer.
Primary liver cancer is a common malignant tumor in the world. Its pathogenesis is concealed and clinically asymptomatic. It is mostly in the middle and late stages of the disease. It is often combined with different degrees of cirrhosis. The liver function reserve is poor.About 80% of patients are in the first place. The operation has been lost at the time of diagnosis. Primary liver cancer is not sensitive to conventional treatments such as radiotherapy and chemotherapy because of its unique tissue type. For advanced liver cancer, ablation combined with other systemic treatments is expected to alleviate the patient's condition, prolong the patient's survival time, and benefit more patients. The long-term clinical efficacy of tumor thermal ablation has been reported more, the basic conclusion is consistent, hat is, the 5-year survival rate of early stage tumors such as liver cancer less than 3cm is not inferior to surgical resection, or even better. Liver cancer is rich in blood supply and tumor blood vessels are dense. The formation and maintenance of these blood vessels requires pro-angiogenic signals, of which VEGFR is a key component. Apatinib is a small molecule tyrosine kinase inhibitor that inhibits VEGFR at very low concentrations. SHR-1210 is a humanized anti-programmed cell death receptor 1 antibody. This study was designed to evaluate the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for the treatment of advanced liver cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Evaluation of the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for advanced liver cancer.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-Free-Survival(PFS)
The period between the onset of treatment from the onset of treatment, the observation of disease progression, or the death of any cause.
Time frame: Up to two years
Objective response rate (ORR) according to RECIST 1.1
The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period.
Time frame: Up to approximately two years
Disease control rate(DCR)
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Time frame: Up to approximately two years
Overall survival(OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
Time frame: Up to approximately two years
Overall survival rate of 6 months and 12 months
Overall survival rate of 6 months and 12 months.
Time frame: 6 months and 12 months
Safety: incidence and grade of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
The incidence and grade of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Time frame: Up to approximately two years
Quality of life score(QOL)
Quality of life score(QOL)0-100
Time frame: Up to approximately two years
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