This study is being done to analyze the safety, tolerability, and efficacy of treatment using combination of SAM and anti-PD-1/PDL1 antibodies for patients with advanced hepatocellular carcinoma.
This is a study of combination anti-PD-1/PD-L1 antibodies and S-adenosyl-methionine (SAM) for adult patients (≥18) with advanced hepatocellular carcinoma. SAM is a compound found naturally in the body and is available as a dietary supplement in the U.S. SAM is a prescription drug in China treating liver disease and advanced HCC with poor liver function under certain circumstances. Also, SAM has recently been shown to play a key role regulating cancer cell proliferation trough epigenetic pathway. Anti-PD-1/PD-L1 antibodies (including pembrolizumab, nivolumab, sintilimab, toripalimab, camrelizumab, tislelizumab and atezolizumab etc.) are given intravenously at assigned dose. Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal. This study is aimed to evaluate the safety and efficacy of the combination of SAM and PD-1/PD-L1 monoclonal antibody in unresectable late-stage HCC patients.
Study Type
OBSERVATIONAL
Enrollment
20
Intravenous injection at indicated dose for at least 6 months
Taken orally at indicated dose for at least 6 months
Zhongshan Hospital Fudan university
Shanghai, China
RECRUITINGIncidence of adverse events
Safety will be monitored by addressing and recording all adverse events (AEs), serious adverse events (SAEs) and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Time frame: Up to 30 days after last treatment dose
Objective response rate(ORR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
Progression free survival(PFS)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
To the relief time (TOR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
Duration of relief(DOR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
Disease Control Rate (DCR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 2 years
6-month survival rate
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 6 months
12-month survival rate
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 12 months
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