Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463444
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-19
Brief Title:
Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models
Sponsor:
Chen Xiaoping
Organization:
Tongji Hospital
Study Overview
Official Title:
Precision Treatment of Unresectable Liver Cancer Based on Multi-omics Deep Learning Model a Multi-center Prospective Single-arm Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Surgery is the main curative treatment for hepatocellular carcinomaHCC patients but 70-80 of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected Local and systemic therapy are the main treatments for unresectable HCC Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates ORR as high as 433 to 771
Detailed Description:
Surgery is the main curative treatment for hepatocellular carcinomaHCC patients but 70-80 of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected Local and systemic therapy are the main treatments for unresectable HCC Two recent trials of HAIC combined with PD-1 antibody and targeted therapy reported objective response rates ORR as high as 433 to 771 However the selection of patients who will benefit from the therapy remains a major challenge for the individualized treatment of HCC which requires more accurate prediction of combination therapy
With the advancement of sequencing technology more and more fine-grained biological data can be obtained including radiomics pathology genomics and immunomics In recent years the development of new methods such as graph neural network and multi-scale PHATE makes it possible to integrate multi-omics data The use of artificial intelligence models to integrate multimodal data is an effective means to predict treatment response more accurately which is helpful for more accurate and detailed classification of patients with different treatment outcomes and to explore the internal mechanism of treatment response or not
We constructed a multi-omics deep learning prediction model based on the retrospective cohort data from multiple medical centers who received HAIC combined with target therapy and immunotherapy The model could better distinguish the patients who would benefit from combination therapy with an AUC of 086
Therefore the investigators conducted this multicenter prospective single-arm study to explore the response and prognosis of combination therapy in a population screened by the model and to evaluate the predictive power of the model
With the advancement of sequencing technology more and more fine-grained biological data can be obtained including radiomics pathology genomics and immunomics In recent years the development of new methods such as graph neural network and multi-scale PHATE makes it possible to integrate multi-omics data The use of artificial intelligence models to integrate multimodal data is an effective means to predict treatment response more accurately which is helpful for more accurate and detailed classification of patients with different treatment outcomes and to explore the internal mechanism of treatment response or not
We constructed a multi-omics deep learning prediction model based on the retrospective cohort data from multiple medical centers who received HAIC combined with target therapy and immunotherapy The model could better distinguish the patients who would benefit from combination therapy with an AUC of 086
Therefore the investigators conducted this multicenter prospective single-arm study to explore the response and prognosis of combination therapy in a population screened by the model and to evaluate the predictive power of the model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None