Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542796
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Through a retrospective study of patients who underwent comprehensive treatment for hepatocellular carcinoma at the Second Affiliated Hospital of Zhejiang University we explored the risk factors related to the sensitivity of comprehensive treatment We used the PD-L1 expression level of patients before comprehensive treatmentcharacteristic morphology of tertiary lymphoid structures as well as other parameters are used to construct a liver cancer comprehensive treatment efficacy evaluation model Using this liver cancer comprehensive treatment efficacy evaluation model we conducted a randomized controlled trial on whether to receive comprehensive treatment for liver cancer patients to verify the accuracy and practical value of the model
Detailed Description:
As of 2020 hepatocellular carcinoma HCC is the sixth leading cause of cancer-related deaths making it one of the worlds major public health issues The incidence of HCC is increasing year by year from 14 million cases worldwide in 2012 to an estimated 22 million cases by 2030 Most HCC patients are not diagnosed until late stages thus missing the optimal treatment window In recent years comprehensive therapy with immune targeting as the core has made breakthrough progress in the treatment of advanced liver cancer bringing good news to patients with advanced liver cancer Clinical trials have shown that immunotherapy combined with targeted therapy is effective in the treatment of unresectable hepatocellular carcinoma Patients have significant clinical value However the therapeutic effect of immune targeting varies depending on the complex tumor microenvironment of HCC Therefore there is an urgent need to establish an efficacy evaluation model for comprehensive treatment to accurately classify and stratify patients and select the best treatment plan
Intratumoral T cell and B cell infiltration has been extensively studied and is associated with good prognosis in most tumors In recent years tertiary lymphoid structures TLS have gradually gained in-depth understanding Tertiary lymphoid structures are lymphatic aggregates formed at sites of inflammation in autoimmune diseases infections and cancers They can provide local antigen presentation sites and generate effector T cells and central memory T cells thereby providing humoral and cellular anti-tumor specificity Sexual immune response provides an important microenvironment Further studies have shown that the presence of intratumoral TLS is associated with reduced risk of recurrence and improved survival in most solid tumors and mature TLS was found to be a key site of tumor-specific immune responses in pancreatic ductal adenocarcinoma which is consistent with immunotherapy related to efficacy In addition more and more studies have found that clinical characteristics such as vascular endothelial growth factor VEGF levels are related to the effect of comprehensive treatment of liver cancer Studies have shown that plasma VEGF levels are significantly related to the survival rate of patients with hepatocellular carcinoma and VEGF levels are important for their prognosis Stratification has excellent clinical value
Therefore this study focused on the characteristic parameters of liver cancer tumor microenvironment such as TLS PD-L1 expression level and VEGF level to construct a liver cancer comprehensive treatment efficacy evaluation model to guide the selection of treatment options
The predictive accuracy of the constructed model was determined by measuring the specificity sensitivity and area under the receiver operating characteristic ROC curve in the validation sample Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation usually expressed as the area under the ROC curve A predictive model with an ROC of 075 is considered to have good discrimination whereas an area of 05 is considered equivalent to a coin toss
Intratumoral T cell and B cell infiltration has been extensively studied and is associated with good prognosis in most tumors In recent years tertiary lymphoid structures TLS have gradually gained in-depth understanding Tertiary lymphoid structures are lymphatic aggregates formed at sites of inflammation in autoimmune diseases infections and cancers They can provide local antigen presentation sites and generate effector T cells and central memory T cells thereby providing humoral and cellular anti-tumor specificity Sexual immune response provides an important microenvironment Further studies have shown that the presence of intratumoral TLS is associated with reduced risk of recurrence and improved survival in most solid tumors and mature TLS was found to be a key site of tumor-specific immune responses in pancreatic ductal adenocarcinoma which is consistent with immunotherapy related to efficacy In addition more and more studies have found that clinical characteristics such as vascular endothelial growth factor VEGF levels are related to the effect of comprehensive treatment of liver cancer Studies have shown that plasma VEGF levels are significantly related to the survival rate of patients with hepatocellular carcinoma and VEGF levels are important for their prognosis Stratification has excellent clinical value
Therefore this study focused on the characteristic parameters of liver cancer tumor microenvironment such as TLS PD-L1 expression level and VEGF level to construct a liver cancer comprehensive treatment efficacy evaluation model to guide the selection of treatment options
The predictive accuracy of the constructed model was determined by measuring the specificity sensitivity and area under the receiver operating characteristic ROC curve in the validation sample Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation usually expressed as the area under the ROC curve A predictive model with an ROC of 075 is considered to have good discrimination whereas an area of 05 is considered equivalent to a coin toss
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None